双气囊小肠镜（DBE）和胶囊内镜（CE）对可疑小肠疾病诊断价值研究
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摘要
研究背景
小肠是人体消化道最长的器官,由于传统侵袭性检查手段的限制,如推进式内镜(push enteroscopy,PE)只能进入近端小肠对小肠病变进行诊治,结肠镜也只能进入回肠末端进行观察,因此,既往小肠被认为是消化道检查的盲区。既往认为小肠疾病(small bowel diseases, SBDs)发病率较低,临床表现非特异,小肠又位于消化道较深的位置,SBDs的诊断和后续治疗常常被延迟,给SBDs患者造成严重的经济负担和不良的预后,这就使得SBDs的早期识别、诊断和干预在临床实践中显得极为重要。随着胶囊内镜(capsule endoscopy, CE)和气囊辅助内镜(balloon-assisted enteroscopy, BAE)的临床应用,使得SBDs得以及时的诊断,同时又可以获得小肠粘膜的病理学诊断,从而使SBDs诊治进入了一个新时代。
CE,又称无线胶囊内镜(wireless CE),是本世纪初消化内镜领域一项重大发明,最初由以色列Given公司研发和生产。相对于传统的非侵袭性小肠检查如利用放射学检查的消化道钡餐、CT, CE能随自身肠蠕动对肠道粘膜进行观察,具有非侵袭性、无放射性危害、较高的病变检出率和较少并发症等特点,临床上已广泛应用于消化道检查。许多临床试验表明CE对于可疑SBDs、不明原因消化道出血(obscure gastrointestinal bleeding,OGIB)、可疑和确诊的小肠肿瘤(small bowel tumors, SBTs)、可疑和确诊的克罗恩病(Crohn's diseases, CD),其研究结果几乎都一致性的认为CE对SBDs具有较高的诊断阳性率。
双气囊小肠镜(Double-balloon enterosocope, DBE)于2001年首次报道,2003年全球进入临床应用。相对于传统的PE, DBE克服了PE在插镜长度上只能检查近端小肠的限制,DBE能进镜到达深部小肠以发现更多的病变,且可以任意退镜对小肠进行观察、对发现的病变进行活检、标记和治疗等,目前已广泛应用于消化道疾病的诊治,DBE也已被许多临床研究证实对可疑SBDs、OGIB、SBTs. CD具有较高的诊断阳性率,是一种安全有效的诊治手段。DBE不仅可用于SBDs的诊治,也可用于上消化道疾病、结直肠疾病、胆胰疾病和胃肠道术后解剖学改变者消化道疾病的诊治,是21世纪内镜技术发展的重大进步。
Meckel's憩室(Meckel's diverticulum,MD)是出生时存在于小肠一种的先天性真性憩室,也是胃肠道最常见的一种先天性畸形。群体流行病学研究表明,MD发生于不到2%的人群,且多见于男性,多于儿童期及以后发病,可终生无症状。MD虽然少见,但其并发症常常能导致严重的后果,如急性消化道出血导致失血性休克、穿孔造成严重感染性腹膜炎、肠梗阻、肠套叠等。当前临床上MD的诊断比较困难,术前诊断阳性率较低,常常因其他疾病进行手术时偶然发现或手术探查时发现。虽然DBE和CE已在临床广泛应用,且许多研究对两者在消化道疾病的诊断阳性率进行比较(如OGIB、可疑CD、SBTs等),但关于两者对于MD的临床诊断报道极少,对于MD诊断的比较性研究更是缺乏。
胃肠道间叶组织肿瘤(gastrointestinal mesenchymal tumors,GIMTs)是常见的SBDs之一,包括肌源性肿瘤、神经源性肿瘤和胃肠道间质瘤,约占整个消化道肿瘤的10%。既往检查小肠GIMTs可用钡剂造影或CT,钡餐或钡灌肠对较大的腔内型SBTs具有较好的临床应用价值,CT检查可疑SBTs主要用于定位、评估肿瘤病变的浸润及其远处转移。虽然SBTs在整个消化系统肿瘤性疾病中较为少见,但GIMTs在SBTs中却很常见,且可位于小肠各段。已有的许多研究表明,CE和BAE对于诊断小肠肿瘤比其他传统的方法具有更高的敏感性和特异性,因此小肠GIMTs的真实发病率可能会更高。既往关于DBE用于诊断可疑SBTs的研究表明,DBE是一种能够准确诊断SBTs的安全、有效的手段。但迄今为止,关于DBE和CE对GIMTs诊断进行比较研究者更是极少,且少有研究对GIMTs的临床和内镜特点进行报道。
CE的应用对传统的临床影像学检查产生了巨大冲击。许多临床研究表明,CE不仅具有非侵袭性、无放射学暴露的优点,而且对可疑SBDs产生较高的诊断阳性率。因此,许多研究建议并推荐CE作为可疑SBDs一线的首选检查手段。即使这样,小肠影像学检查在检查可疑和已知SBDs中仍发挥着重要作用。CT在最近几年已经广泛用于小肠的检查,包括小肠CT灌肠(CT enteroclysis, CTEc)和小肠CT成像(CT enterography,CTEg)。CTE在小肠影像学的作用也随着螺旋CT和多排探头CT(multidetector row CT,MDCT)技术的发展在逐渐地扩展和演变。CTEc克服了钡灌肠和传统CT检查的缺陷,结合了两者的优点使其融合为一个检查手段,并使其应用简化,即利用插入的鼻十二指肠管注入造影剂,结合螺旋CT或MDCT,使其结果更为可靠。临床研究表明,由于具有较好的耐受性和易于操作的特点,这种检查对于可疑的SBDs、SBTs、CD都是一种有效诊断手段。CTEg首次于1997年由Raptopoulos等人报道,是一种非侵袭性、口服造影剂进行小肠评估的检查手段,通过口服大量的肠内造影剂,获得肠腔充分的扩张,结合CT良好的空间和时间分辨率,从而识别肠腔内、肠壁和肠腔外的病变。随后的研究表明,CTEg对可疑SBDs是一种准确的诊断手段,包括对肠道内、肠壁和肠道外的病变诊断。磁共振成像(Magnetic resonance imaging,MRI)在近几年对于可疑SBDs的应用正起着越来越重要的作用,包括小肠MRI灌肠(MR enteroclysis,MREc)和小肠MRI成像(MR enterography, MREg)。MRI具有良好的软组织对比、无离子辐射、扫描快速等特点,小肠内外的异常可通过交叉平面的影像进行检查,MRE可通过充分的肠道充盈获得,同时结合对比增强和一些功能性的信息,有助于SBDs的准确诊断,其优越性逐步显现。
当前,对于小肠内镜和小肠影像学检查在可疑SBDs诊断中的应用仍存在很大的争议(CE与CTE和MRI临床应用)。许多临床研究认为,对于SBDs的诊断,CE较其他传统方法有较高的诊断阳性率,推荐CE作为可疑SBDs首选一线检查手段。但也有其他一些研究表明,CE对于以腹痛或腹泻的可疑SBDs患者诊断阳性率较低,对这些患者CE不应被推荐为可疑SBDs的首选检查手段。但是CE对于内镜和放射学检查阴性的患者,在9%的人群能获得明确的诊断。也有学者认为,CTE和MRE对于许多SBDs患者的诊断价值已经足够,CE检查应该省略或推迟于后续使用,而CTE和MRE应该作为可疑或已确诊CD患者首选的一线检查手段。还有有研究认为,CE可检出更多的小肠病变,明显优于CTE和MRI,CE对SBDs的诊断其主要作用,CE与CTE或MRI在SBDs诊断中应相互补充。在CE、CTE、MRE三种检查手段中,CE与MRI没有放射损害。既往的系统回顾和meta分析均得出一致性的结论：CE明显优于其他方式(包括CTE,然而纳入研究太少是其缺陷所在),而CE对SBDs的诊断是否优于MRI却没有给出明确结论。目前尚未关于CE与CTE或MRI对SBDs诊断价值进行系统评价的报道。
研究目的
1.通过回顾性分析单中心9年的DBE应用经验,探讨中国人群的SBDs特点；
2.通过回顾性研究,探讨DBE和CE对MD的临床诊断价值；
3.通过回顾性研究,探讨DBE和CE对GIMTs的临床诊断价值以及GIMTs临床和内镜特点；
4.通过循证医学研究对CE、CTE、MRI对可疑2或已确诊的SBDs诊断价值进行系统评价,为临床实践应用提供可靠的循证医学证据。
资料和方法
广州南方医院消化科是中国最早开展小肠镜检查的内镜单位之一,2003年引进日本富士DBE内镜系统,2005年引进国产OMOM胶囊内镜系统。
1.单中心DBE诊治可疑SBDs9年应用经验
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)-2012年5月所有经历DBE检查者的临床资料,包括患者的人口统计学数据、DBE检查前其他检查、DBE适应症、DBE检查结果、活检阳性率、DBE检查后的后续管理等等进行分析。
2.DBE和CE对MD临床诊断价值
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)到2011年12月经历DBE和/或CE并行外科手术及病理学检查的患者,对最后确诊为MD患者的数据进行收集,分析DBE/CE对MD患者的诊断阳性率,并对患者进行随访。3.DBE和CE对胃肠道间叶组织肿瘤(gastrointestinal mesenchymal tumors, GIMTs)的临床诊断价值以及GIMTs临床和内镜特点
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)-2011年12月经历DBE和/或CE的783名可疑SBDs患者的内镜数据,分析最后确诊为GIMTs患者的临床资料,包括人口统计学数据、DBE检查前其他检查、GIMTs在小肠的位置、DBE检查的内镜结果、GIMTs病变切除方式、组织病理学结果和术后管理等。
4.系统评价CE与CTE/MRI对可疑或已确诊的SBDs诊断价值
基于计算机辅助的检索策略,通过检索四大电子数据库Medline (January2001-November2012),EMbase (January2001-November2012), Cochrane central register of controlled trials (January2001-November2012), Web of Knowledge (January2001-November2012)检索有关CE与CTE/MRI比较相关文献。为了检索尽可能相关的潜在文献,我们进行了手工检索,主要对著名的国际会议摘要进行检索。额外潜在的相关文献主要检索所获得的文章的参考文献,主要是reviews和meta分析。主要评估结果是CE与CTE/MRI对可疑/已确诊SBDs总的诊断阳性率,次要评估结果包括CE与CTE/MRI对可疑／已确诊CD诊断阳性率,以及对可疑／已确诊SBTs、OGIB患者诊断阳性率。
统计方法
回顾性分析中所有数据使用统计分析软件SPSS17.0进行分析。连续性变量用均数、均数±SD表示,非连续性数据用频率或百分比表示。分类变量资料比较用χ2检验或Fisher's确切概率。CE和DBE检查结果一致性分析采用kappa系数：kappa值<0.4表明一致性较差；0.4-0.7表明一致性中等；>0.7表明一致性较好。DBE和CE对MD/GIMTs的诊断比较用McNemar's χ2检验(即配对χ2检验)。P值<0.05(双侧)认为结果具有统计学意义。
系统评价和]meta分析采用STATA/SE version11.2进行分析。非连续性变量的效应量大小用比值比(odds risks,ORs)表示,均差用95%置信区间(95%confidence interval,95%CI)表示。P值<0.05被认为具有统计学意义。经Q统计量检验法如发现无统计学差异,采用固定效应模型(Mantel-Haenszeli法)进行分析。研究间的异质性通过计算I2统计量,将I2=50%作为研究具有异质性分界点,当I2>50%and P<0.05时,统计分析采用随机效应模型。研究发表偏倚用漏斗图评估并用Egger's and Begg's tests检测。敏感性分析基于研究设计。亚组分析分别基于CTEc和ICTEg,MREc和MREg。
结果
1.单中心DBE诊治可疑SBDs9年应用经验
825人经历DBE检查,平均患者年龄41.3±16.3岁,最小年龄8岁,最大年龄84岁。男性患者占全部小肠镜检查患者的71.3%。超过一半的患者(50.2%)经历DBE检查的适应症为OGIB,其中显性出血占39.2%,隐性出血11.0%；其次适应症为腹痛(36.8%)、腹胀(3.8%)、体格检查(3.8%)、呕吐(1.7%)、乏力(0.8%)、体重下降(0.5%)。
所有患者都进行常规检查如血液、大小便常规检查、心电图、X线检查、腹部B超检查。患者行DBE检查前至少进行过一次其他辅助检查,如胃镜(79.0%)、结肠镜(80.7%)、腹部CT(23.5%)、钡剂造影(20.1%)、核素扫描(8.1%)、血管造影(4.8%)、骨髓穿刺(3.0%)、推进式小肠镜(2.5%)、磁共振检查(2.2%)。上述相关检查并未获得明确诊断结论。
在825名患者中,262名患者接受CE检查,其中两名患者于DBE检查后接受CE检查,两种检查间隔时间超过两周,且均未发现小肠病变。在DBE检查前两周内有260名患者进行CE检查,发现病变或可疑存在病变有187名患者,其病变检出率为71.9%；150人做出明确诊断,诊断阳性率为57.7%。17名患者出现并发症,其中CE滞留14名患者(5.3%),13例CE滞留发生于小肠多发溃疡患者,肠梗阻1例,电池耗完未完成检查1例,检查过程中发生数据线脱落并及时连接1例。在260名先后经历CE和DBE检查的患者中,DBE检查明确诊断188名患者,两中检查对可疑SBDs诊断比较见表1。*P=1.000.
所有接受DBE检查患者均为中国人群,其中经历经口DBE检查294人(35.6%),经肛DBE检查231人(28.0%),经口+经肛DBE检查300入(36.4%),通过单侧(本研究中为经口DBE)或双侧DBE检查完整检查小肠达120人,完整小肠检查率为14.5%。
经口DBE发现病变368人,病变检出率44.6%；经肛DBE发现病变284人,病变检出率34.4%。DBE检查发现病变后行内镜下活检385人,其中活检得出明确诊断54人,内镜活检阳性率14.0%。DBE检查最终发现602名患者存在胃肠道病变,包括胃镜检查和结肠镜检查漏诊分别为5名(0.6%)和11名患者(1.3%),其总的病变检出率为73.0%,最后作出明确诊断为552人,诊断阳性率为66.9%。根据临床检查及后续诊疗结果,最终确定624名患者明确具有胃肠道病变,608名患者最终确定小肠存在病变,其中586名患者由DBE发现病变。炎症性／感染性病变是已确诊SBDs中最常见的病变,占50.2%,之后是原发性小肠肿瘤(20.2%)、肠管异常(16.0%)、血管病变(5.1%)、转移性小肠肿瘤(1.5%)、其他混杂性病变(7.1%)。
根据最后确诊结果,基于发现小肠病变的部位,病变位于回肠(25.6%),空肠(24.6%),多发部位(16.7%),十二指肠(5.6%),小肠系膜(0.1%)。发现SBDs的患者均接受相应治疗,包括药物治疗、内镜干预(组织活检、止血、取出滞留的CE、息肉切除)、外科手术(275例,包括确诊的MD和小肠肿瘤)。3名患者接受术中内镜检查,包括Bean综合征1例,急性消化道大出血2例。
所有接受DBE检查的患者中,5例患者出现并发症。1例经肛DBE检查后24小时内出现肠穿孔,术后证实穿孔由憩室并发溃疡导致；2例接受经口DBE后出现轻度胰腺炎并经保守治疗后出院；2例患者在检查过程中出现外套管气囊破裂,重新更换外套管后患者完成检查,患者检查后未诉任何不适。少数经口DBE检查患者诉检查后咽喉部不适,未予特殊处理。1名患者接受术中DBE检查,但由于出血量较大,且内镜下表现为活动性出血,并未发现出血部位,患者术后因急性消化道失血性休克死亡。1名患者因其他疾病死亡。
2.DBE和CE对MD的临床诊断价值
783名可疑SBDs患者经历1071次DBE检查,其中74名患者经历DBE、外科手术和术后病理证实为MD患者。患者平均年龄29.0±14.3岁(8-76岁),主要表现为黑便或便血(64例)、腹痛(8例)、腹泻(2例)。其中26例MD患者在进行DBE检查前接受过CE检查。一些患者在入院前经历过钡餐检查(15例)、CT检查(12例)、数字减影血管造影(6例)、磁共振检查(2例)。
26名患者在CE和DBE检查前后接受了ECT检查,其中20名患者在CE和／或DBE之前接受检查,14名患者获得阴性结果,3名患者可疑诊断为MD,明确诊断3名患者。在CE或/DBE之后检查的6名患者,5名患者诊断为阳性。
所有患者均成功完成了DBE检查,一名患者在DBE检查后24小时内发生持续性腹痛和间断性呕吐,最后经手术证实是由MD穿孔引起的急性腹膜炎。1名患者接受了内镜下止血。与最后手术和病理结果相比,DBE对MD的诊断阳性率为86.5%(64/74)。其中6名患者经历了经口DBE检查,DBE诊断MD4例患者,1名患者未发现病变,1例患者见到显性大量的活动性出血,由于活动性出血影响内镜视野,并未发现原发出血病变。45例患者接受了经肛DBE检查,只有5例患者未明确诊断,包括3例被误诊为间质瘤,1例误诊为肠道重复畸形,1例因为大量的出血影响内镜视野,未发现病变部位。23名患者经历经肛和经口DBE检查,完成全小肠的检查有10人,其中明确诊断MD20例患者(全部通过经肛途径),发现显性出血1例,未发现病变2例。
在未明确诊断或误诊的10名患者中,患者接受开腹或者腹腔镜手术切除误诊为间质瘤的患者3人、肠道重复畸形1人、因MD穿孔急诊外科手术1人。另外5名患者接受ECT检查,4人可疑诊断为MD,1人阴性,随后5人接受外科剖腹探查定位和手术切除病变部位。所有被误诊为间质瘤的患者最后由外科手术和病理确诊。
手术和术后病理证实,憩室炎是MD患者最常见的病变,占40.5%(30例患者),之后是MD伴异位胃粘膜,占31.1%(23例),MD伴溃疡(20.3%,15例), MD伴异位胃粘膜和异位胰腺(5.4%,4例),MD伴异位胰腺(2.7%,2例)。
26名患者经历CE和DBE检查,CE检查全部在DBE检查之前，检查间隔时间在2周内。1名患者因发现CE设备的数据连接线脱落,并告知检查医生及时连接。所有患者成功完成CE检查。26人接受了37次DBE检查,DBE检查过程中和检查后并未诉明显不适。DBE对MD的诊断阳性率为84.6%,明显高于CE的诊断阳性率(7.7%, P<0.000, McNemar's x2test), DBE和CE的一致性较差(Kappa=0.03)。
所有患者术后接受以电话随访形式的随访,时间从1月～5年不等,所有患者在术后临床症状消失,无再出血和需要输血的病史。值得注意的是,4名患者(3名男性,1名女性)在术后2年在我院诊断为小肠CD并在我院接受治疗。
3.DBE和CE对GIMTs的临床诊断价值以及GIMTs临床和内镜特点
77名患者经历DBE检查并被病理学检查和／外科手术证实患有小肠GIMTs.患者平均年龄47.7±14.1岁(20-77岁),63.6%为男性。患者主要表现为OGIB(81.8%),其次为腹痛(10.4%)。所有患者在DBE检查前均接受过其他检查至少1次,包括胃镜(73例)、肠镜(66例)、PE(1例),所有检查均未做出明确诊断。10名患者接受消化道钡餐检查,只有1名诊断为可疑小肠肿瘤。12名患者接受CT检查,2名被诊断为小肠肿瘤,1名患者被诊断为可疑小肠肿瘤。2名接受MRI检查的患者被诊断为可疑小肠肿瘤。接受血管造影(2例)、Mekecl's scan(3例)、骨髓穿刺(2例)也未作出明确诊断。
31名患者在DBE检查前2周内接受CE检查。11名患者被CE明确诊断为小肠肿瘤,8名患者为可疑诊断,其他12名患者均未发现任何病变。CE检查过程中均未出现任何并发症。31名患者经历37次DBE检查,包括22次经口DBE检查、3次经肛DBE检查、6次经口和经肛DBE检查。DBE和CE诊断小肠GIMTs敏感性分别为93.5%和61.3%。DBE诊断小肠GIMTs明显优于CE(P＝0.006,McNemar's χ2test)。
77名患者经历了93次DBE检查,包括49次经口DBE检查,12次经肛DBE检查,16次经口和经肛DBE检查。完成全小肠检查患者3人,均通过经口和经肛DBE检查。71名患者由DBE发现小肠病变,病变检出率92.2%；DBE明确诊断GIMTs68人,诊断阳性率88.3%。DBE行内镜下活检41人,活检病理证实5名GIMTs患者,活检阳性率12.2%。1名患者接受内镜下行治愈性GIMT切除,病变大小约8mm,病理证实病变为平滑肌瘤。所有患者均成功完成DBE检查,检查中和检查后均未出现相关并发症。
9名DBE未明确诊断的患者,1名患者DBE发现活动性出血影响内镜视野而未发现具体病变位置,2名患者由DBE分别发现空肠单个溃疡性病变。6名患者DBE未发现任何病变,包括2名经口和经肛DBE检查患者(均未完成全小肠检查),1名只行经口DBE检查,另外3名只行经肛DBE检查。所有未明确诊断患者由于持续性的症状转诊至外科接受腹腔镜或剖腹探查术。5名患者术后证实GIMTs向肠腔外生长,1名只接受经口DBE检查患者术后证实GIMT位于回肠。
绝大多数GIMTs患者经由DBE检查并明确诊断。绝大多数GIMTs内镜表现为小肠单发病变,向肠腔内突起。最常见的小肠GIMTs其粘膜表面常常是不光滑的,表现为糜烂或溃疡的外观。GIMTs第二种常见的内镜特点为肠腔肿瘤具有光滑的小肠粘膜,表现为卵圆形或椭圆形的宽基肿物。罕见有GIMTs内镜表现为不规则形状。
本研究中,术后病理证实的小肠GIMTs包括小肠间质瘤(gastrointestinal stromaltumor, GIST)(60例)、平滑肌瘤(6例)、脂肪瘤(3例)、血管瘤(3例)、淋巴管瘤(3例)、纤维组织细胞瘤(1例)、血管肉瘤(1例)。基于肿瘤原发部位,所有GIMTs经手术和术后病理证实均是小肠原发肿瘤。两种类型的GIMTs在本研究中被发现,包括腔内型和腔外型肿瘤,其中腔内型GIMTs最常见且由手术证实。除2名患者为小肠多发淋巴管瘤,余下所有患者均为单发肿瘤性病变。且本研究发现,GIMTs最常见部位位于空肠(60例),其次见于回肠(16例),较少见的部位是十二指肠(1例)。术后证实所有GIMTs并未发生周围浸润、远处转移和扩散。
所有小肠GIMTs患者接受治愈性切除,病变切除后临床症状消失,患者自觉明显改善。所有患者术后接受平均14.5个月电话随访,所有患者并无与DBE和手术相关报道。
4.CE与CTE/MRI对可疑或已确诊的SBDs诊断价值的系统评价
4.1CE与CTE对可疑/已确诊SBDs诊断比较
本研究纳入15篇文献,8个研究采用CTEc,7个研究采用CTEg。所有研究CE均采用以色列Given公司CE系统。
15篇文献纳入475名个体,包括4篇回顾性研究。所有研究均报告CE与CTE对SBDs的诊断阳性率。合并结果显示,CE在SBDs的诊断上优于CTE (OR=1.94,95%CI1.03-3.65;P=0.039),主要是与CTEc比较(OR=2.94,95%CI1.42-6.09;P=0.004),对于CTEg来说,CE并不占有优势(OR=1.20,95%CI0.45-3.22;P=0.714)。由于异质性检验发现合并研究间存在统计学差异(χ2=19.8;P<0.001,I2=75.0%),因此采用随机效应模型。
4篇文献纳入OGIB患者比较CE和CTE的诊断效能,共纳入114名患者。合并结果显示CE和CTE对于OGIB患者诊断效能相当(OR=1.20,95%CI0.71-2.05; P=0.50)。异质性检验无统计学差异,因此采用固定效应模型(χ2=3.51;P=0.319,I2=14.6%)。
9篇文献纳入241名可疑和已确诊CD患者对CE和CTE进行比较,其中7篇文献纳入已确诊CD患者。合并结果显示,CE总体来说在可疑和已确诊CD患者诊断上优于CTE (OR=2.77,95%CI1.24-6.17; P=0.013),但主要是与CTEc比较(OR=4.11,95%CI1.88-8.97;P<0.001),在与CTEg比较上,两者诊断效能相当(OR=2.16,95%CI0.71-6.61;P=0.176)。异质性检验发现存在统计学差异,因此采用随机效应模型(χ2=22.84;P<0.004,I=65.0%)。
纳入研究中有4篇文献比较CE与CTE对可疑和已确诊SBTs诊断价值比较。合并结果显示,CE和CTE对可疑和已确诊SBTs具有相似的诊断阳性率(OR=0.4,95%CI0.03-4.92;P=0.48),异质性检验存在统计学差异,因此采用随机效应模型(χ2-7.9; P=0.019,I2=74.7%)。
在检测发表偏倚的过程中,统计学异质性存在于CE与CTE对SBDs总的诊断阳性率比较、可疑和已知CD诊断阳性率比较、可疑和已知SBTs诊断阳性率比较,对OGIB患者的比较中并未发现存在异质性。漏斗图评估并未发现明显的不对称,Egger's and Begg's tests也并未检测到明显的发表偏倚(Egger's test:P=0.502)。敏感性分析基于研究设计,排除4篇回顾性分析文献后,其总的合并结果并未发现明显改变。
4.2CE与MRI对可疑/已确诊的SBDs诊断比较
本研究纳入17篇文献,7篇文献纳入已知SBDs的研究受试者,6篇文献纳入可疑和已确诊SBDs的研究受试者,余下的文献纳入可疑SBDs研究受试者。
17个研究纳入526名可疑和已确诊SBDs个体比较CE和MRI的诊断阳性率。异质性检验χ2=52.01; P<0.001,I2=69.2%;因此采用随机效应模型。合并结果显示CE在对可疑和已确诊的SBDs诊断上并不优于MRI (OR=1.51,95%CI0.89-2.56;P=0.127).亚组分析表明CE与不同方式MR诊断效能也是相当的,无论是MREg (OR=1.53,95%CI0.83-2.84;P=0.174)还是MREc (OR=1.02,95%CI0.37-2.86; P=0.963).
4个研究针对CE和MRI对OGIB患者的诊断阳性率比较。合并OR值(OR=3.88,95%CI1.83-8.23; P<0.001))表明,在以OGIB为症状的可疑SBDs患者中,CE在诊断阳性率上明显优于MRI。异质性检验并无统计学意义(x2=3.21;P=0.36; I2=6.7%)。
8个研究纳入可疑和已确诊CD患者并对CE和MRI进行比较。合并结果显示两种检查手段的诊断效能相当(OR=0.92,95%CI0.44-1.93; P=0.832)(χ2=16.15; P=0.024;I2=56.6%)。
7个研究纳入可疑和已确诊SBTs患者比较CE和MRI的诊断效能,其中五个研究纳入已知家族性腺瘤息肉病(known familial adenomatous polyposis,FAP)患者或黑斑息肉病(Peutz-Jeghers' syndrome, PJS)患者。合并结果显示CE和MRI在诊断可疑和已确诊SBTs并无明显差异(OR=1.30,95%CI0.47-3.55; P=0.614)。由于存在统计学异质性,因此,采用随机效应模型(heterogeneity χ2=9.57; P=0.048;I2=58.2%)。
结论
1.结合国内其他研究结果,本研究结果在一定程度上再次证实了中国人群的SBDs特点,炎症性／感染性疾病、原发性小肠肿瘤和小肠肠管畸形是当前单中心人群研究最常见的小肠病变；进一步来说,DBE在本研究的应用再次证实DBE是一种安全、有效的诊治可疑SBDs的内镜手段,即使是一种侵袭性检查,但DBE能提供病变的相对准确部位并能进行某些治疗性操作,可以在临床实践中广泛推广和应用；基于国内SBDs诊治现况,我们提出一个适合中国人群应用可疑SBDs诊断流程以供临床实践参考。
2.CE和DBE对发现小肠糜烂／溃疡性病变,特别是多发病变,病变检出率较高,且一致性较好；但CE检查前需确认小肠有无严重狭窄,且CE所见病变并非都是可信的；
3.DBE对小肠病变常规活检阳性率较低,对于DBE检查时发现病变,特别是溃疡性病变,建议除常规病理学检查外,免疫组织化学检查作为常规检查,便于排除可能存在的恶性病变,因为内镜活检的常规病理也并非都可信。
4.对于高度可疑的MD患者,特别是有症状的男性患者,相对于CE,DBE是一种更有效的、可靠的检查手段,基于解剖学的考虑,经肛DBE检查是一种具有较高的诊断准确性的插镜途径。阴性的Meckel's scan不能排除MD的存在,进一步来说,阴性的CE结果也不能排除重要小肠病变的存在,当高度可疑小肠病变时,即使在CE阴性的情况下,DBE也是必要的。
5.对于内镜发现MD,无论是否出现并发症,只要无手术禁忌症,建议治愈性切除(手术／内镜)；提出小肠可疑憩室诊断流程供临床实践所参考。
6.DBE对于小肠GIMTs的病变检出率明显优于CE,还可在镜下进行标记,能为后续手术切除病变提供精确的定位；对于DBE发现可疑小肠间叶组织肿瘤,在无法保证内镜切除成功的情况下,建议不做活检,仅作标记。
7.小肠GIMTs内镜常表现为小肠单发病变,并突向肠腔。最常见的GIMTs其粘膜表面常常是不光滑的,表现为糜烂或溃疡的外观；其次是具有光滑的小肠粘膜,表现为卵圆形或椭圆形的宽基隆起肿物；罕见有内镜下表现为不规则形状。
8.CE对可疑SBDs诊断上优于CTEc,并不优于CTEg;对OGIB患者和可疑／已确诊的SBTs/CD患者,当前研究表明CE在诊断效能上并不优于CTE；除了CE对OGIB患者的诊断阳性率优于MRI外,无论是在SBDs总的诊断效能还是对可疑／已确诊的CD/SBTs患者,其CE诊断价值与MRI相当。CE与CTE/MRI起着相互补充的作用具有更大应用价值和临床意义。
Background
Small bowel (SB) is the longest part of entire gastrointestinal tract and considered as a blind spot in the past because of limitations of traditional methods such as push enteroscopy (PE) and colonoscopy. Conventional endoscopes can be performed to investigate proximal SB and terminal ileum, respectively. Small bowel diseases (SBDs) has low prevalence and nonspecific manifestations, plus deep location in the digestive tract, the diagnosis and treatment of patients with SBDs may be delayed, contributing to huge medical cost and poor prognosis. Early identification, diagnosis and timely intervention of SBDs become extremely important in clinical practice. With advent of capsule endoscopy (CE) and balloon-assisted enteroscopy (BAE), patients with SBDs can be early diagnosed and treated by theses advanced techniques with endoscopic biopsy(BAE), their application innovates a new era for diagnostics and management of SBDs.
CE, also known as wirelesses CE, was initially invented and developed by Given Image Corp. at the beginning of this century. Compared with traditional noninvasive methods such as small bowel barium study and CT, CE can be performed to investigate the entire SB according intestinal movements because of its characteristics of noninvasiveness, non-radioactive hazard, higher detection rate and fewer complications. Currently, CE has been widely used in clinical practice. The findings of numerous clinical trials showed that CE has high diagnostic yields in patients with suspected SBDs, obscure gastrointestinal bleeding (OGIB), suspected/ known small bowel tumors(SBTs), suspected/known Crohn's diseases (CD).
Double-balloon enterosocopy (DBE) was firstly reported in2001and applied into clinical practice in2003. Compared with traditional invasive PE, DBE with two balloons at the end of the overtube and the enteroscopy overcomes the shortcomings of length of PE, which can be operated to grip the intestine by inflating the balloon so as to insert into distal SB. In addition, DBE can be performed by endoscopist back and forth to conduct biopsy, positional mark and therapeutic management. Similarly, a lot of clinical trials have confirmed that DBE has high diagnostic yields in patients with suspected SBDs, OGIB, SBTs, CD and has excellent safety in clinical practice. Currently, DBE can be not only used to investigate the SB, but also performed to investigate the upper gastrointestinal tract, the lower digestive tract, biliary tract and altered gastrointestinal anatomy. The application of DBE is a major progress of endoscopic technology development in the21st century.
Meckel's diverticulum(MD) is the most common congenital malformation in the gastrointestinal tract, which is a true diverticulum. Epidemiological studies show that MD occurs in less than2%of the population and more common in men, which is divided into symptomatic MD and asymptomatic MD. Symptomatic MD is frequently found in childhood and the aldults, and asymptomatic MD may not be examined during the lifetime of patient with MD. Although it is rare, complications of MD may lead to uncontrolled hemorrhagic shock arising from acute gastrointestinal bleeding, serious infectious peritonitis from intestinal perforation, intestinal obstruction/intussusception, etc. Currently, preoperative diagnosis of MD is relative low and MD is found incidentally by surgical exploration. There are few reports regarding to diagnosis of MD by DBE or CE although the both methods have been used to be compared each other in patients with OGIB, suspected CD and SBTs. As far as comparative diagnosis of patients with MD is concerned, there is lack of clinical study for comparison between CE and DBE.
Gastrointestinal mesenchymal tissue tumors (GIMTs), including myogenic tumors, neurogenic tumors and gastrointestinal stromal tumor (GISTs), account for less than10%of gastrointestinal tumors. Radiological imagings(such as barium study, computed tomography(CT) and angiography) is usually performed to examine small bowel GIMTs without the application of CE and double-balloon enteroscopy (DBE). Barium study is feasible for diagnosis of biggish intraluminal SBTs; CT is used to locate the lesion, assess for invasion and detect metastasis of SBTs. GIMTs are common in the different part of SB. Their true incidences might be higher than those studies reported previously because novel methods such as CE and BAE are much more sensitive and specific in diagnosing GIMTs than conventional methods. Several studies indicated that DBE is a safe and effective procedure that enables accurate diagnosis of SBTs. To date, few studies have reported the diagnosis of GIMTs by DBE and elucidated their clinical and endoscopic features. Furthermore, rare studies have compared diagnosis of GIMTs by DBE and CE.
The application of CE poses a significant challenge on conventional radiological examinations. Moreover, number of publications and experts suggested that CE should be a first-line tool for diagnosis of SBDs because of its advantages of invasiveness and higher diagnostic yield when compared with traditional methods. Even so, radiologic imaging still plays an important role in the diagnosis of patients with suspected/established SBDs. CT has become a widely used technique for examining the SB in recent years, either by CT enteroclysis(CTEc)or by CT enterography(CTEg). The role of CTE in the diagnosis of SBDs has been gradually expanded and evolving with recent technical advances of spiral and multidetector row CT (MDCT) technology. CTEc overcomes the individual deficiencies of both barium enteroclysis and conventional CT and combines the advantages of both into one technique whose clinical applicability has been simplified and made more reliable with spiral and MDCT. Number of clinical trials suggested that this technique is reliable method in the diagnostics of SBDs due to its characteristics of well-tolerance and easy to perform, either for suspected/known SBTs or for suspected/established Crohn's disease (CD). CTEg was first described by Raptopoulos et al, which is an noninvasive peroral method of evaluating the SB by obtaining good distention and combines the improved spatial and temporal resolution of CT with large volumes of ingested enteric contrast material to permit visualization of the SB wall and lumen. Following studies revealed that CTEg is an accurate diagnostic imaging for SBDs, including luminal and extraluminal pathology. Magnetic resonance imaging (MRI) technique has also evolved as a powerful tool in recent years and is playing an increasing role of in the evaluation of SBDs, especially application of MR enteroclysis/enterography (MREc and MREg). Strengths of MRI include the superior soft-tissue contrast, lack of ionizing radiation, and the implementation of fast scanning techniques. Furthermore, both extraluminal and intraluminal abnormalities can be investigated through cross-sectional imaging. And that adequate luminal distention is achieved by MRE, combined with contrast enhancement and functional information, help to make an accurate diagnosis. Several studies have shown the advantages of this technique over traditional enteroclysis due to improvements in spatial and temporal resolution combined with improved bowel distending agents. Currently, there are still controversies in the diagnosis of SBDs between CTE/MRI and CE. Firstly, the findings of a crowd of clinical trials and perspectives proposed by experts suggested that CE should be the first-line tool for evaluation of suspected SBDs due to its higher yield when compared with other traditional modalities, excellent safety and rare complications. However, other studies showed that CE has a low yield for evaluation of suspected SBDs in patients with abdominal pain or diarrhea and cannot be recommended as a first-line test without further study. But it facilitates diagnosis in9%of patients with negative endoscopic and radiologic examinations. Secondly, some experts suggested that the diagnostic value of MRE and CTE is sufficient for clinical management of most patients with suspected SBDs, and thus CE may be omitted or at least postponed for later usage. CTE and MRE should be the first-line modality in the imaging of CD and is considered the most appropriate imaging modality in patients with suspected CD. The third point of view is that CE detects more SB lesions and is greatly superior to CTE/MRE for diagnosing SBDs, CE plays a major role and CTE/MRE only acts as a complementary and selective role. Fourthly, the three modalities play complementary role in the diagnostics of SBDs. As three different kinds of alternative modalities in clinical practice, CTE/MRI and CE are performed to compare their diagnostic yield of SBDs because there is still debatable problem. However, the results from clinical trials are inconclusive and contradictory. To date, there is no meta-analysis published to compare these methods and evaluate the diagnostic yields. To assess diagnostic efficiency of the these modalities for investigation of SBDs, we undertook a meta-analysis of studies that reported head-to-head comparison of diagnostic yield between CTE/MRI and CE.
Objectives
1. To retrospectively analyze the data of patients who underwent DBE from a single center with nine year's experience, and elucidate the characteristics of SBDs in a single-center Chinses population;
2. To retrospectively analyze the observational data collected from patients who underwent examination with CE, DBE, or both to evaluate DBE in the diagnosis of MD and to compare its diagnostic yield with that of CE.
3. To retrospectively analyze the data collected from patients who underwent examination with DBE, CE, or both to evaluate DBE in the diagnosis of GIMTs and to compare its diagnostic yield with that of CE.
4. To compare diagnostic performance of CE, CTE and MRI in patients with suspected SBDs based on evidence-based medince.
Materials and Methods
Department of Gastroenterology, Nanfang Hospital in Guangzhou is one the earliest endoscopic unit with introduction of small bowel endoscopy in China. DBE system was introduced in2003and domestic OMOM CE system was introduced in2005.
1. DBE for diagnosis of suspected SBDs:nine-years' experience from a single-center
A retrospective analysis was conducted from the data of patients who underwent a DBE procedure in a single-center with nine years' experience in China (from2003to May2012), including collection of demographic data, other inspections prior to DBE procedure, indications for DBE, positive biopsy rate, management after DBE examination.
2. DBE and/or CE for diagnostic value of MD
The current study was to assess the value of DBE in the diagnosis of MD and comparatively evaluate the diagnostic yield of DBE and CE for MD. A single-center study was performed on patients with a confirmed diagnosis of MD by surgery and postoperative pathology between January2003and December2011. A follow-up was conducted as well.
3. DBE and/or CE for to diagnosis of GIMTs, and analysis of clinical and endoscopic features of GIMTs
A retrospective review in a total of783patients who underwent a DBE procedure from January2003to December2011was conducted. Data from patients with pathologically confirmed GIMTs were analyzed at a single tertiary center with nine years'experience. The primary outcomes assessed included characteristics of patients with GIMTs, indications for DBE, overall diagnostic yield of GIMTs, endoscopic morphology, positive biopsy, comparison of diagnosis with CE, and subsequent interventional management.
4. Systematic review and meta-analysis for diagnosis of suspected/known SBDs between CE and CTE/MRI
Based on computer-aided strategy, we searched electronic database Medline (January2001-November2012), EMbase (January2001-November2012), Cochrane central register of controlled trials (January2001-November2012), Web of Knowledge (January2001-November2012). Abstracts published in international conferences and potential literatures were performed by manual search. Studies regarding head-to head comparison CE with CTE/MRI were included. Main outcomes assessed inlucded diagnostic yield of CE CTE/MRI, the second outcomes evaluated were diagnostic yields of suspected/confirmed CD, suspected/confirmed SBTs, and patients with OGIB.
Statistical analysis
Data analysis of retrospective study was performed by statistical software SPSS version17.0for Windows. Continuous data were presented as means, mean±SD or range, and categorical variables were expressed as frequency or percentages. The x2 test or Fisher's exact probability test was used to compare differences in categorical variables examined. Agreement analysis was assessed by the Kappa statistic:a kappa value<0.4indicates poor agreement, between0.4and0.7indicates moderate agreement, and>0.7indicates good agreement. McNemar'sχ2test (namely pairedχ2test) was used to compare the diagnostic yields between CE and DBE. A P value<0.05(two-sided) was considered statistically significant.
The software STATA/SE version11.2(Stata, College Station, TX) was used to conduct statistical analysis of data synthesis and analysis. Effect size for pooled discontinuous variables was expressed as odds risks (ORs) and mean difference with95%confidence interval (95%CI). P value<0.05was considered statistically significant. The heterogeneity cross studies was evaluated by calculating the I2statistic of inconsistency with a cutoff point of I2=50%. And then random effect model was used when I2statistic>50%and P value<0.05. Publication bias was evaluated by funnel plot and examined by the Egger's and Begg's tests. Subgroup analysis was conducted on the basis of CTEc and CTEg, MREc and MREg. Sensitivity analysis was conducted based on the study design.
Results
1. Nine years' experience of DBE application in patients with suspected SBDs at a single center
A total of825patients underwent DBE investigation, with mean age41.3±16.3years (range8-84years). Male accounted for71.3%of all the patients. Obscure gastrointestinal bleeding(OGIB) was the most common indication for DBE investigation, accounting for50.2%(39.2%of overt-OGIB and11.0%occult-OGIB, respectively), followed by abdominal pain (36.8%), abdominal distention (3.8%), patient's requirement for screening (3.8%), diarrhea (2.4%), vomiting (1.7%), debilitation(0.8%), weight loss(0.5%).
Blood test, defecate convention examination (including fecal occult blood testing), ECG, abdominal X-ray and abdominal ultrasound were regularly performed in the patients registered in our care unit. Each patient received at least one kind of other medical examination, including colonoscopy (80.7%), gastroscopy (79.0%), computed tomography (CT)(23.5%), barium study (20.1%), Meckel's scan (8.1%), angiography (4.8%), bone marrow aspiration (3.0%), push entroscopy(2.5%), magnetic resonance imaging (MRI)(2.2%). Patients with confirmed diagnosis were not obtained by above examinations.
262patients received CE examination; two of them receive CE after DBE procedure beyond duration of two weeks and has no diagnosis by CE.260of them patients received CE prior to DBE within an interval of two weeks. CE identified lesions/suspected lesions in187patients, definite diagnosis was finally determined in150patients (57.7%). Complications occurred in17patients (6.5%), including incomplete intestinal obstruction (1case), incomplete entire SB examination because of CE with running out of charge (1case), timely reconnection after disconnection of the CE data line (1case), CE retention (14cases). CE retention primarily occurred in patients with intestinal ulcers and stricture (13cases).260patients who received tandom CE and DBE,188of them were definitely diagnosed by DBE. Comparison of diagnostic yield between CE and DBE was seen in Table1.
*P=1.000.
A total of825patients underwent1159DBE procedures, including antegrade approach for294patients, retrograde approach for231patients and combination of the two approaches for300patients. Total enteroascopy (antegrade approach alone or antegrade+retrograde approachs) was achieved in120patients (14.5%).
368patients with SBDs were identified by antegrade DBE, with44.6%of lesion detection rate;284patients with SBDs were identified by retrograde DBE, with34.4%of lesion detection rate.385patients received endoscopic biopsy, positive biopsy was achieved in54of them and the positive biopsy rate was14.0%.
602patients with lesions (with73.0%of lesion detection rate) were detected by DBE, including missed lesions in the stomach and the colon in5cases (0.6%) and11cases (1.3%), respectively.552patients with SBDs were definitely diagnosed by DBE, and the diagnostic yield was66.9%. Finally,624patients with confirmed diagnosis had gastrointestinal lesions based on following management, including608patients with SBDs. Inflammatory/infectious diseases were the most common findings of SBDs, with a proportion of50.2%. Next was primary SB tumor (SBT)(20.2%), followed by abnormalities of intestinal tube (16.0%), vascular lesions (5.1%), metastatic intestinal tumor (1.5%), other miscellaneous lesions (7.1%).
Based on confirmed location of lesion, intestinal lesions were most frequently detected in the ileum (25.5%), followed by the jejunum (24.6%), multiple parts of the SB(16.7%), duodenum (5.6%).
Patients with confirmed SBDs received medical treatment such as pharmacotherapy, endoscopic intervention (tissue sampling, homeostasis, CE retrieval (CE retrieval was successfully performed by DBE in8patients), polyp resection, and surgical procedure (275cases, including all patients with MD and SBTs). Three patients underwent intraoperative endoscopy (including1case with Bean syndrome,
2cases with acute massive gastrointestinal bleeding).
Five patients occurred adverse events during and after DBE procedures. Intestinal perforation arised from MD with ulcer was recorded in one case after retrograde DBE and was verified by surgical procedure. Two patients had mild pancreatitis after oral DBE procedures and received conservative therapy. Rupture of a balloon equipped with the overtube was reported in two patients during the antergrade and the retrgrade procedure, respectively, patients with discomfort was not recorded. The patients completed DBE investigation after a new overtube was equipped. A few patients complained of mild laryngeal discomfort after the peroral approach, without special treatment.1patient died from acute massive hemorrhagic shock because the casue of hemorrhage was not found by intraoperative DBE. Another patient died from other diseases.
2. DBE and/or CE for diagnosis of MD
A total of783patients underwent1071DBE procedures for diagnosis or interventions of gastrointestinal diseases. Of these patients, a definite diagnosis of MD was established in74inpatients by surgery and postoperative pathological examination after DBE. With a mean age of29.0±14.3years (range,8±76years), the patients underwent DBE mainly for melena/hematochezia (64cases), abdominal pain (8cases), or diarrhea (2cases). Of the74MD patients,26patients also underwent CE before DBE. Some patients had previous examinations with a gastrointestinal barium study (15cases), computed tomography (12cases), digital subtraction angiography (6cases), or magnetic resonance imaging (2cases) before admission into our center.
A total of26patients received a traditional Meckel's scan before and after both methods. It was performed in20patients before CE and/or DBE and yielded negative results in14cases, suspected diagnosis of MD in3cases, and definite diagnosis of diverticula in3cases. After CE and/or DBE, Meckel's scan was used in6patients and yielded positive results in5cases.
All74patients successfully completed the preoperative DBE procedure. Only one patient complained of persistent abdominal pain and intermittent vomiting after DBE, which was found to result from acute peritonitis caused by diverticulum perforation, as confirmed by subsequent surgery. One patient underwent an endoscopic intervention for hemostasis. Compared with the operative and pathologic diagnosis, preoperative DBE showed a diagnostic yield of DBE of86.5%(64/74) for MD.
Six patients underwent DBE via the peroral approach, which resulted in clear diagnoses of MD in4cases, one without lesion and one with overt massive bleeding in the ileum. Forty-five patients underwent DBE via the peranal approach, and only5had definite diagnoses other thanMD, including3with suspected gastrointestinal stromal tumors (GISTs), one with misdiagnosed intestine duplication, and another without lesions because of massive bleeding. The remaining23patients were examined with a combination of both approaches, and total enteroscopy was successfully completed in10patients. The combined approaches resulted in the diagnosis of MD in20cases (all found via a retrograde approach), detected overt bleeding in1case (via a combined approach), and identified no obvious lesions in2cases.
In the10patients with no definite diagnoses or misdiagnoses by DBE, open or laparoscopic surgeries were carried out for removal of the suspicious masses (GIST) in3cases, intestine duplication in one case, and emergency surgery was performed in1case for perforation of the diverticulum. The other5patients underwent subsequent Meckel's scintigraphy, and a suspected diagnosis of diverticulum was made in4patients, who then received exploratory laparotomy to locate the site of gastrointestinal bleeding. Inverted MD initially misdiagnosed as GISTs by DBE in3cases was finally confirmed by an operative procedure and pathology.
Operative and pathologic findings demonstrated that single diverticulitis was the most common pathology in the MD lesions (40.5%), followed by diverticulum with concurrent ectopic gastric mucosa (31.1%), diverticulitis associated with ulcer (20.3%), diverticulum with ectopic gastric mucosa and pancreatic tissues (5.4%), and diverticulum with heterotopic pancreatic tissues (2.7%).
All26patients undergoing both CE and DBE procedures completed the examinations successfully. CE was easily swallowed and excreted by the patients without any complications, as confirmed by X-ray. In one case, the data line of CE was disconnected from the image recorder but soon reconnected. A total of37DBE procedures were performed in the26patients, and no patients complained of obvious discomfort during or after the procedure. The overall diagnostic yield of DBE for MD was84.6%, which was significantly greater than that of CE (7.7%, P<.000, McNemar'sx2test). Poor agreement was found between the findings of DBE and CE (kappa=0.03).
All patients received a range of1month to5years follow-up in the form of a telephone interview; the clinical symptoms disappeared after the operative procedure was performed. It was notable that4(3males and1female) were diagnosed as having small bowel Crohn's disease2years after surgery and received treatment in our center.
3. DBEand CE for diagnosis of small bowel GIMTs and characteristics of small bowel GIMTs
A total of77inpatients who underwent DBE were identified; their final diagnoses were confirmed as GIMTs by histopathology and/or surgery. The mean age was47.74±14.14years (range:20-77years), with63.6%being males. The majority of patients presented with GI bleeding, accounting for81.8%, followed by abdominal pain, accounting for10.4%.
All the patients underwent other medical examinations prior to DBE, including gastroduodenoscopy (73cases), colonoscopy (66cases), and push enteroscopy (1case), and yielded negative or suspected diagnoses. Barium study was conducted in10patients, only one patient was suspected of having a SBT. Twelve patients received CT scan, SBT was found in two patients and suspected SBT was found in one patient. Two patients were found to have suspected SBT by magnetic resonance imaging,2by angiography,3by Meckel's scan and2by bone marrow aspiration.
Thirty-one patients underwent CE examination before DBE within an interval of two weeks. All patients successfully completed CE procedures which reached the colon. Positive diagnoses were made in11patients, and suspected diagnoses in8 patients. No lesion was detected in12patients. No complications occurred during and after the procedure.Thirty-seven DBE procedures were performed in31patients, including22antegrade approaches,3retrograde approaches, and6combinations of the two approaches. The sensitivity of DBE and CE for the diagnosis of GIMTs was93.5%and61.3%, respectively. DBE for the diagnosis of GIMTs was superior to CE (P=0.006, McNemar's χ2test).
A total of93DBE procedures were performed in77patients, including49antegrade DBE approaches,12retrograde DBE approaches and16combinations of the two approaches. Total enteroscopy (TE) was achieved in3patients. Lesions were found in the small bowel in71patients, the detection rate for GIMTs being92.2%. Clear diagnosis was established in68patients, and the diagnostic yield of DBE for GIMTs was88.3%. Multiple tissue samplings were made in41cases; positive diagnoses were obtained in5cases. Only one therapeutic procedure was performed in one patient, i.e., a leiomyoma (8mm) was removed by DBE. All the patients successfully completed the entire DBE procedure, without any complications occurring during and after the procedure.
Among9patients with unclear diagnosis by DBE, one was found with overt, ongoing bleeding, and two were found with single ulcerative lesions in proximal small bowel, respectively. No abnormality was found in six patients, including two patients treated with the combination of the two approaches (neither completed TE), one with the antegrade approach, the other three with the retrograde approach. Patients with indefinite diagnoses underwent surgical procedures (laparotomy or laparoscopic exploration) because of persistent symptoms. Five patients had GIMTs with extraluminal growth confirmed by surgery; one patient undergoing the antegrade approach had a GIMT located in the ileum.
Endoscopic diagnosis was established in the overwhelming majority of the patients. Most GIMTs presented as a single lesion under the endoscopic view, protruding into the intra-luminal mass in the small bowel. The unsmooth surface of the tumor was seen most frequently, showing the appearance of erosion or ulcer. The second frequent morphology was a mass with smooth surface, indicating a tumor with sessile base in a rounded or oval shape. Rare GIMTs presented with irregular shapes under endoscopic view.
In this study, GIMTs with confirmed diagnoses included GIST (60cases), leiomyoma (6cases), lipoma (3cases), hemangioma (3cases), lymphangioma (3cases), fibrous histiocytoma (1case), and angiosarcoma (1case). Based on the primary sites of tumors, GIMTs in our study were all primary tumors verified surgically and pathologically. Two kinds of GIMTs were detected on the basis of site, including intra-and extra-luminal tumors. Intra-luminal GIMTs were detected most frequently and verified by endoscopy and surgery (Figures1,2). A single lesion was most frequently examined, except in two patients who had multiple lymphangiomas. GIMTs were detected most frequently in the jejunum (60cases), and next in the ileum (16cases) and duodenum (1case). No spread and metastasis was investigated and confirmed after surgical removal.
The findings of DBE changed the therapeutic plan and enabled all the patients to receive early intervention. The clinical symptoms disappeared after surgery and all the patients felt an improvement in their conditions. They received an average follow-up time of14.5mos after intervention, and important improvements were obtained in the patients after DBE and surgical intervention. No complication was reported.
4. Results of meta-analysis for comparison diagnosis of suspected/known SBDs between CE and CTE/MRI
4.1Results of meta-analysis for comparison diagnosis of suspected/known SBDs between CE and CTE
4.1.1Comparison of overall diagnostic yield between CE and CTE
15trials met the inclusion criteria,8of them performed CT enteroclysis, and seven of them performed CT enterography. CE used in the included studies was a product of Given Corp.15trials involved a total of475individuals, including4retrospective studies. All of included studies reported the diagnostic yield of comparison between CE and CTE. CE was superior to CTE in the diagnosis of SBDs (OR=1.94,95%CI1.03-3.65;P=0.039), mainly for comparison with CT enteroclysis (OR=2.94,95%CI1.42-6.09;P=0.004), not with CT enterography(OR=1.20,95%CI0.45-3.22; P=0.714). Random-effect model was used because significantly statistical heterogeneity was detected cross the studies (x2=19.8; P<0.001,12=75.0%), but with no evidence of funnel plot asymmetry(Egger's and Begg's tests, P>0.05, respectively).
4.1.2Comparison of diagnostic yield between CE and CTE in patients with OGIB
4studies reported diagnostic yields of CE and CTE in patients with OGIB, in total of114individuals. CE and CTE had comparable diagnostic yields in patients with OGIB (OR=1.2,95%CI0.71-2.05; P=0.50). No statistical heterogeneity was noted between studies (x2=3.51; P=0.319,I2=14.6%).
4.1.3Comparison of diagnostic yield between CE and CTE in patients with
suspected and established CD
9studies comparing CE with CTE involved in241subjects,7of which included patients with established CD. The pooled data indicated that CE was generally superior to CTE in the diagnosis of suspected and known CD (OR=2.77,95%CI1.24-6.17; P=0.013), mainly for comparison with CT enteroclysis(OR=4.11,95%CI1.88-8.97; P<0.001), not with CT enterography(OR=2.16,95%CI0.71-6.61; P=0.176), with statistical heterogeneity between studies(x2=22.84;P<0.004, I2=65.0%).
4.1.4Comparison of diagnostic yield between CE and CTE in patients suspected and established SBTs
4studies compared the yield of CE with CTE for the diagnosis of suspected and known SBTs. CE and CTE provided similar diagnostic yields in patients with suspected and known SBTs (OR=0.4,95%CI0.03-4.92; P=0.48), with significant heterogeneity cross the studies(x2=7.9; P=0.019,I2=74.7%).
4.2Results of meta-analysis for comparison diagnosis of suspected/known SBDs
between CE and MRI
4.2.1Comparison of overall diagnostic yield between CE and MRI
17studies (including three abstracts) were identified for comparison between CE and MRI in patients with suspected and established SBDs.7of included trials incorporated patients with known SBDs,6included patients with suspected and known SBDs, remains included patients with suspected SBDs.
17trials included526individuals for comparison CE with MRI in the diagnostics of suspected and established SBDs. Pooled analysis indicated that CE was not superior to MRI for diagnosis of SBD(OR=1.51,95%CI0.89-2.56; P=0.127). Statistical heterogeneity was detected between the studies (x2=52.01; P<0.001, I2=69.2%) and thus a random effects model was applied. Subgroup analysis indicated that CE had similar diagnostic performance compared with MREg (OR=1.53,95%CI0.83-2.84; P=0.174) or MREc (OR=1.02,95%CI0.37-2.86; P=0.963).
4.2.2Comparison CE with MRI in patients with OGIB
4studies were identified for comparison of diagnostic performance between CE and MRI. CE provided higher diagnostic yield than that of MRI in patients with OGIB. The OR was3.88(95%CI1.83-8.23;P<0.001). There was no significant heterogeneity cross the studies (heterogeneity x2=3.21; P=0.36; I2=6.7%).
4.2.3Comparison of CE and MRI in patients with suspected and established CD
8trials were identified to compare CE with MRI in patients with suspected and known CD. Both modalities yielded similar diagnostic performance (OR=0.92,95%CI0.44-1.93;P=0.832)(heterogeneity x2=16.15; P=0.024;I2-=56.6%).
4.2.4Comparison of CE and MRI in patients with suspected and established SBTs
7trials recruited patients with suspected/established SBTs for comparison CE with MRI. Five of them included individuals with known familial adenomatous polyposis (FAP) or with established Peutz-Jeghers' syndrome (PJS). Diagnostic efficacy of CE was not significantly different from that of MRI (OR=1.30,95%CI0.47-3.55; P=0.614). A random effects model was used because of statistical heterogeneity (heterogeneity x2=:9.57; P=0.048;I2=58.2%).
Conclusions
1. Combing previous reports from scatterd Chinese population, the current findings show that inflammatory/infectious diseases, pri
小肠是人体消化道最长的器官,由于传统侵袭性检查手段的限制,如推进式内镜(push enteroscopy,PE)只能进入近端小肠对小肠病变进行诊治,结肠镜也只能进入回肠末端进行观察,因此,既往小肠被认为是消化道检查的盲区。既往认为小肠疾病(small bowel diseases, SBDs)发病率较低,临床表现非特异,小肠又位于消化道较深的位置,SBDs的诊断和后续治疗常常被延迟,给SBDs患者造成严重的经济负担和不良的预后,这就使得SBDs的早期识别、诊断和干预在临床实践中显得极为重要。随着胶囊内镜(capsule endoscopy, CE)和气囊辅助内镜(balloon-assisted enteroscopy, BAE)的临床应用,使得SBDs得以及时的诊断,同时又可以获得小肠粘膜的病理学诊断,从而使SBDs诊治进入了一个新时代。
CE,又称无线胶囊内镜(wireless CE),是本世纪初消化内镜领域一项重大发明,最初由以色列Given公司研发和生产。相对于传统的非侵袭性小肠检查如利用放射学检查的消化道钡餐、CT, CE能随自身肠蠕动对肠道粘膜进行观察,具有非侵袭性、无放射性危害、较高的病变检出率和较少并发症等特点,临床上已广泛应用于消化道检查。许多临床试验表明CE对于可疑SBDs、不明原因消化道出血(obscure gastrointestinal bleeding,OGIB)、可疑和确诊的小肠肿瘤(small bowel tumors, SBTs)、可疑和确诊的克罗恩病(Crohn's diseases, CD),其研究结果几乎都一致性的认为CE对SBDs具有较高的诊断阳性率。
双气囊小肠镜(Double-balloon enterosocope, DBE)于2001年首次报道,2003年全球进入临床应用。相对于传统的PE, DBE克服了PE在插镜长度上只能检查近端小肠的限制,DBE能进镜到达深部小肠以发现更多的病变,且可以任意退镜对小肠进行观察、对发现的病变进行活检、标记和治疗等,目前已广泛应用于消化道疾病的诊治,DBE也已被许多临床研究证实对可疑SBDs、OGIB、SBTs. CD具有较高的诊断阳性率,是一种安全有效的诊治手段。DBE不仅可用于SBDs的诊治,也可用于上消化道疾病、结直肠疾病、胆胰疾病和胃肠道术后解剖学改变者消化道疾病的诊治,是21世纪内镜技术发展的重大进步。
Meckel's憩室(Meckel's diverticulum,MD)是出生时存在于小肠一种的先天性真性憩室,也是胃肠道最常见的一种先天性畸形。群体流行病学研究表明,MD发生于不到2%的人群,且多见于男性,多于儿童期及以后发病,可终生无症状。MD虽然少见,但其并发症常常能导致严重的后果,如急性消化道出血导致失血性休克、穿孔造成严重感染性腹膜炎、肠梗阻、肠套叠等。当前临床上MD的诊断比较困难,术前诊断阳性率较低,常常因其他疾病进行手术时偶然发现或手术探查时发现。虽然DBE和CE已在临床广泛应用,且许多研究对两者在消化道疾病的诊断阳性率进行比较(如OGIB、可疑CD、SBTs等),但关于两者对于MD的临床诊断报道极少,对于MD诊断的比较性研究更是缺乏。
胃肠道间叶组织肿瘤(gastrointestinal mesenchymal tumors,GIMTs)是常见的SBDs之一,包括肌源性肿瘤、神经源性肿瘤和胃肠道间质瘤,约占整个消化道肿瘤的10%。既往检查小肠GIMTs可用钡剂造影或CT,钡餐或钡灌肠对较大的腔内型SBTs具有较好的临床应用价值,CT检查可疑SBTs主要用于定位、评估肿瘤病变的浸润及其远处转移。虽然SBTs在整个消化系统肿瘤性疾病中较为少见,但GIMTs在SBTs中却很常见,且可位于小肠各段。已有的许多研究表明,CE和BAE对于诊断小肠肿瘤比其他传统的方法具有更高的敏感性和特异性,因此小肠GIMTs的真实发病率可能会更高。既往关于DBE用于诊断可疑SBTs的研究表明,DBE是一种能够准确诊断SBTs的安全、有效的手段。但迄今为止,关于DBE和CE对GIMTs诊断进行比较研究者更是极少,且少有研究对GIMTs的临床和内镜特点进行报道。
CE的应用对传统的临床影像学检查产生了巨大冲击。许多临床研究表明,CE不仅具有非侵袭性、无放射学暴露的优点,而且对可疑SBDs产生较高的诊断阳性率。因此,许多研究建议并推荐CE作为可疑SBDs一线的首选检查手段。即使这样,小肠影像学检查在检查可疑和已知SBDs中仍发挥着重要作用。CT在最近几年已经广泛用于小肠的检查,包括小肠CT灌肠(CT enteroclysis, CTEc)和小肠CT成像(CT enterography,CTEg)。CTE在小肠影像学的作用也随着螺旋CT和多排探头CT(multidetector row CT,MDCT)技术的发展在逐渐地扩展和演变。CTEc克服了钡灌肠和传统CT检查的缺陷,结合了两者的优点使其融合为一个检查手段,并使其应用简化,即利用插入的鼻十二指肠管注入造影剂,结合螺旋CT或MDCT,使其结果更为可靠。临床研究表明,由于具有较好的耐受性和易于操作的特点,这种检查对于可疑的SBDs、SBTs、CD都是一种有效诊断手段。CTEg首次于1997年由Raptopoulos等人报道,是一种非侵袭性、口服造影剂进行小肠评估的检查手段,通过口服大量的肠内造影剂,获得肠腔充分的扩张,结合CT良好的空间和时间分辨率,从而识别肠腔内、肠壁和肠腔外的病变。随后的研究表明,CTEg对可疑SBDs是一种准确的诊断手段,包括对肠道内、肠壁和肠道外的病变诊断。磁共振成像(Magnetic resonance imaging,MRI)在近几年对于可疑SBDs的应用正起着越来越重要的作用,包括小肠MRI灌肠(MR enteroclysis,MREc)和小肠MRI成像(MR enterography, MREg)。MRI具有良好的软组织对比、无离子辐射、扫描快速等特点,小肠内外的异常可通过交叉平面的影像进行检查,MRE可通过充分的肠道充盈获得,同时结合对比增强和一些功能性的信息,有助于SBDs的准确诊断,其优越性逐步显现。
当前,对于小肠内镜和小肠影像学检查在可疑SBDs诊断中的应用仍存在很大的争议(CE与CTE和MRI临床应用)。许多临床研究认为,对于SBDs的诊断,CE较其他传统方法有较高的诊断阳性率,推荐CE作为可疑SBDs首选一线检查手段。但也有其他一些研究表明,CE对于以腹痛或腹泻的可疑SBDs患者诊断阳性率较低,对这些患者CE不应被推荐为可疑SBDs的首选检查手段。但是CE对于内镜和放射学检查阴性的患者,在9%的人群能获得明确的诊断。也有学者认为,CTE和MRE对于许多SBDs患者的诊断价值已经足够,CE检查应该省略或推迟于后续使用,而CTE和MRE应该作为可疑或已确诊CD患者首选的一线检查手段。还有有研究认为,CE可检出更多的小肠病变,明显优于CTE和MRI,CE对SBDs的诊断其主要作用,CE与CTE或MRI在SBDs诊断中应相互补充。在CE、CTE、MRE三种检查手段中,CE与MRI没有放射损害。既往的系统回顾和meta分析均得出一致性的结论：CE明显优于其他方式(包括CTE,然而纳入研究太少是其缺陷所在),而CE对SBDs的诊断是否优于MRI却没有给出明确结论。目前尚未关于CE与CTE或MRI对SBDs诊断价值进行系统评价的报道。
研究目的
1.通过回顾性分析单中心9年的DBE应用经验,探讨中国人群的SBDs特点；
2.通过回顾性研究,探讨DBE和CE对MD的临床诊断价值；
3.通过回顾性研究,探讨DBE和CE对GIMTs的临床诊断价值以及GIMTs临床和内镜特点；
4.通过循证医学研究对CE、CTE、MRI对可疑2或已确诊的SBDs诊断价值进行系统评价,为临床实践应用提供可靠的循证医学证据。
资料和方法
广州南方医院消化科是中国最早开展小肠镜检查的内镜单位之一,2003年引进日本富士DBE内镜系统,2005年引进国产OMOM胶囊内镜系统。
1.单中心DBE诊治可疑SBDs9年应用经验
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)-2012年5月所有经历DBE检查者的临床资料,包括患者的人口统计学数据、DBE检查前其他检查、DBE适应症、DBE检查结果、活检阳性率、DBE检查后的后续管理等等进行分析。
2.DBE和CE对MD临床诊断价值
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)到2011年12月经历DBE和/或CE并行外科手术及病理学检查的患者,对最后确诊为MD患者的数据进行收集,分析DBE/CE对MD患者的诊断阳性率,并对患者进行随访。3.DBE和CE对胃肠道间叶组织肿瘤(gastrointestinal mesenchymal tumors, GIMTs)的临床诊断价值以及GIMTs临床和内镜特点
回顾性分析南方医院消化内镜中心电子数据库自DBE使用之初(2003年)-2011年12月经历DBE和/或CE的783名可疑SBDs患者的内镜数据,分析最后确诊为GIMTs患者的临床资料,包括人口统计学数据、DBE检查前其他检查、GIMTs在小肠的位置、DBE检查的内镜结果、GIMTs病变切除方式、组织病理学结果和术后管理等。
4.系统评价CE与CTE/MRI对可疑或已确诊的SBDs诊断价值
基于计算机辅助的检索策略,通过检索四大电子数据库Medline (January2001-November2012),EMbase (January2001-November2012), Cochrane central register of controlled trials (January2001-November2012), Web of Knowledge (January2001-November2012)检索有关CE与CTE/MRI比较相关文献。为了检索尽可能相关的潜在文献,我们进行了手工检索,主要对著名的国际会议摘要进行检索。额外潜在的相关文献主要检索所获得的文章的参考文献,主要是reviews和meta分析。主要评估结果是CE与CTE/MRI对可疑/已确诊SBDs总的诊断阳性率,次要评估结果包括CE与CTE/MRI对可疑／已确诊CD诊断阳性率,以及对可疑／已确诊SBTs、OGIB患者诊断阳性率。
统计方法
回顾性分析中所有数据使用统计分析软件SPSS17.0进行分析。连续性变量用均数、均数±SD表示,非连续性数据用频率或百分比表示。分类变量资料比较用χ2检验或Fisher's确切概率。CE和DBE检查结果一致性分析采用kappa系数：kappa值<0.4表明一致性较差；0.4-0.7表明一致性中等；>0.7表明一致性较好。DBE和CE对MD/GIMTs的诊断比较用McNemar's χ2检验(即配对χ2检验)。P值<0.05(双侧)认为结果具有统计学意义。
系统评价和]meta分析采用STATA/SE version11.2进行分析。非连续性变量的效应量大小用比值比(odds risks,ORs)表示,均差用95%置信区间(95%confidence interval,95%CI)表示。P值<0.05被认为具有统计学意义。经Q统计量检验法如发现无统计学差异,采用固定效应模型(Mantel-Haenszeli法)进行分析。研究间的异质性通过计算I2统计量,将I2=50%作为研究具有异质性分界点,当I2>50%and P<0.05时,统计分析采用随机效应模型。研究发表偏倚用漏斗图评估并用Egger's and Begg's tests检测。敏感性分析基于研究设计。亚组分析分别基于CTEc和ICTEg,MREc和MREg。
结果
1.单中心DBE诊治可疑SBDs9年应用经验
825人经历DBE检查,平均患者年龄41.3±16.3岁,最小年龄8岁,最大年龄84岁。男性患者占全部小肠镜检查患者的71.3%。超过一半的患者(50.2%)经历DBE检查的适应症为OGIB,其中显性出血占39.2%,隐性出血11.0%；其次适应症为腹痛(36.8%)、腹胀(3.8%)、体格检查(3.8%)、呕吐(1.7%)、乏力(0.8%)、体重下降(0.5%)。
所有患者都进行常规检查如血液、大小便常规检查、心电图、X线检查、腹部B超检查。患者行DBE检查前至少进行过一次其他辅助检查,如胃镜(79.0%)、结肠镜(80.7%)、腹部CT(23.5%)、钡剂造影(20.1%)、核素扫描(8.1%)、血管造影(4.8%)、骨髓穿刺(3.0%)、推进式小肠镜(2.5%)、磁共振检查(2.2%)。上述相关检查并未获得明确诊断结论。
在825名患者中,262名患者接受CE检查,其中两名患者于DBE检查后接受CE检查,两种检查间隔时间超过两周,且均未发现小肠病变。在DBE检查前两周内有260名患者进行CE检查,发现病变或可疑存在病变有187名患者,其病变检出率为71.9%；150人做出明确诊断,诊断阳性率为57.7%。17名患者出现并发症,其中CE滞留14名患者(5.3%),13例CE滞留发生于小肠多发溃疡患者,肠梗阻1例,电池耗完未完成检查1例,检查过程中发生数据线脱落并及时连接1例。在260名先后经历CE和DBE检查的患者中,DBE检查明确诊断188名患者,两中检查对可疑SBDs诊断比较见表1。*P=1.000.
所有接受DBE检查患者均为中国人群,其中经历经口DBE检查294人(35.6%),经肛DBE检查231人(28.0%),经口+经肛DBE检查300入(36.4%),通过单侧(本研究中为经口DBE)或双侧DBE检查完整检查小肠达120人,完整小肠检查率为14.5%。
经口DBE发现病变368人,病变检出率44.6%；经肛DBE发现病变284人,病变检出率34.4%。DBE检查发现病变后行内镜下活检385人,其中活检得出明确诊断54人,内镜活检阳性率14.0%。DBE检查最终发现602名患者存在胃肠道病变,包括胃镜检查和结肠镜检查漏诊分别为5名(0.6%)和11名患者(1.3%),其总的病变检出率为73.0%,最后作出明确诊断为552人,诊断阳性率为66.9%。根据临床检查及后续诊疗结果,最终确定624名患者明确具有胃肠道病变,608名患者最终确定小肠存在病变,其中586名患者由DBE发现病变。炎症性／感染性病变是已确诊SBDs中最常见的病变,占50.2%,之后是原发性小肠肿瘤(20.2%)、肠管异常(16.0%)、血管病变(5.1%)、转移性小肠肿瘤(1.5%)、其他混杂性病变(7.1%)。
根据最后确诊结果,基于发现小肠病变的部位,病变位于回肠(25.6%),空肠(24.6%),多发部位(16.7%),十二指肠(5.6%),小肠系膜(0.1%)。发现SBDs的患者均接受相应治疗,包括药物治疗、内镜干预(组织活检、止血、取出滞留的CE、息肉切除)、外科手术(275例,包括确诊的MD和小肠肿瘤)。3名患者接受术中内镜检查,包括Bean综合征1例,急性消化道大出血2例。
所有接受DBE检查的患者中,5例患者出现并发症。1例经肛DBE检查后24小时内出现肠穿孔,术后证实穿孔由憩室并发溃疡导致；2例接受经口DBE后出现轻度胰腺炎并经保守治疗后出院；2例患者在检查过程中出现外套管气囊破裂,重新更换外套管后患者完成检查,患者检查后未诉任何不适。少数经口DBE检查患者诉检查后咽喉部不适,未予特殊处理。1名患者接受术中DBE检查,但由于出血量较大,且内镜下表现为活动性出血,并未发现出血部位,患者术后因急性消化道失血性休克死亡。1名患者因其他疾病死亡。
2.DBE和CE对MD的临床诊断价值
783名可疑SBDs患者经历1071次DBE检查,其中74名患者经历DBE、外科手术和术后病理证实为MD患者。患者平均年龄29.0±14.3岁(8-76岁),主要表现为黑便或便血(64例)、腹痛(8例)、腹泻(2例)。其中26例MD患者在进行DBE检查前接受过CE检查。一些患者在入院前经历过钡餐检查(15例)、CT检查(12例)、数字减影血管造影(6例)、磁共振检查(2例)。
26名患者在CE和DBE检查前后接受了ECT检查,其中20名患者在CE和／或DBE之前接受检查,14名患者获得阴性结果,3名患者可疑诊断为MD,明确诊断3名患者。在CE或/DBE之后检查的6名患者,5名患者诊断为阳性。
所有患者均成功完成了DBE检查,一名患者在DBE检查后24小时内发生持续性腹痛和间断性呕吐,最后经手术证实是由MD穿孔引起的急性腹膜炎。1名患者接受了内镜下止血。与最后手术和病理结果相比,DBE对MD的诊断阳性率为86.5%(64/74)。其中6名患者经历了经口DBE检查,DBE诊断MD4例患者,1名患者未发现病变,1例患者见到显性大量的活动性出血,由于活动性出血影响内镜视野,并未发现原发出血病变。45例患者接受了经肛DBE检查,只有5例患者未明确诊断,包括3例被误诊为间质瘤,1例误诊为肠道重复畸形,1例因为大量的出血影响内镜视野,未发现病变部位。23名患者经历经肛和经口DBE检查,完成全小肠的检查有10人,其中明确诊断MD20例患者(全部通过经肛途径),发现显性出血1例,未发现病变2例。
在未明确诊断或误诊的10名患者中,患者接受开腹或者腹腔镜手术切除误诊为间质瘤的患者3人、肠道重复畸形1人、因MD穿孔急诊外科手术1人。另外5名患者接受ECT检查,4人可疑诊断为MD,1人阴性,随后5人接受外科剖腹探查定位和手术切除病变部位。所有被误诊为间质瘤的患者最后由外科手术和病理确诊。
手术和术后病理证实,憩室炎是MD患者最常见的病变,占40.5%(30例患者),之后是MD伴异位胃粘膜,占31.1%(23例),MD伴溃疡(20.3%,15例), MD伴异位胃粘膜和异位胰腺(5.4%,4例),MD伴异位胰腺(2.7%,2例)。
26名患者经历CE和DBE检查,CE检查全部在DBE检查之前，检查间隔时间在2周内。1名患者因发现CE设备的数据连接线脱落,并告知检查医生及时连接。所有患者成功完成CE检查。26人接受了37次DBE检查,DBE检查过程中和检查后并未诉明显不适。DBE对MD的诊断阳性率为84.6%,明显高于CE的诊断阳性率(7.7%, P<0.000, McNemar's x2test), DBE和CE的一致性较差(Kappa=0.03)。
所有患者术后接受以电话随访形式的随访,时间从1月～5年不等,所有患者在术后临床症状消失,无再出血和需要输血的病史。值得注意的是,4名患者(3名男性,1名女性)在术后2年在我院诊断为小肠CD并在我院接受治疗。
3.DBE和CE对GIMTs的临床诊断价值以及GIMTs临床和内镜特点
77名患者经历DBE检查并被病理学检查和／外科手术证实患有小肠GIMTs.患者平均年龄47.7±14.1岁(20-77岁),63.6%为男性。患者主要表现为OGIB(81.8%),其次为腹痛(10.4%)。所有患者在DBE检查前均接受过其他检查至少1次,包括胃镜(73例)、肠镜(66例)、PE(1例),所有检查均未做出明确诊断。10名患者接受消化道钡餐检查,只有1名诊断为可疑小肠肿瘤。12名患者接受CT检查,2名被诊断为小肠肿瘤,1名患者被诊断为可疑小肠肿瘤。2名接受MRI检查的患者被诊断为可疑小肠肿瘤。接受血管造影(2例)、Mekecl's scan(3例)、骨髓穿刺(2例)也未作出明确诊断。
31名患者在DBE检查前2周内接受CE检查。11名患者被CE明确诊断为小肠肿瘤,8名患者为可疑诊断,其他12名患者均未发现任何病变。CE检查过程中均未出现任何并发症。31名患者经历37次DBE检查,包括22次经口DBE检查、3次经肛DBE检查、6次经口和经肛DBE检查。DBE和CE诊断小肠GIMTs敏感性分别为93.5%和61.3%。DBE诊断小肠GIMTs明显优于CE(P＝0.006,McNemar's χ2test)。
77名患者经历了93次DBE检查,包括49次经口DBE检查,12次经肛DBE检查,16次经口和经肛DBE检查。完成全小肠检查患者3人,均通过经口和经肛DBE检查。71名患者由DBE发现小肠病变,病变检出率92.2%；DBE明确诊断GIMTs68人,诊断阳性率88.3%。DBE行内镜下活检41人,活检病理证实5名GIMTs患者,活检阳性率12.2%。1名患者接受内镜下行治愈性GIMT切除,病变大小约8mm,病理证实病变为平滑肌瘤。所有患者均成功完成DBE检查,检查中和检查后均未出现相关并发症。
9名DBE未明确诊断的患者,1名患者DBE发现活动性出血影响内镜视野而未发现具体病变位置,2名患者由DBE分别发现空肠单个溃疡性病变。6名患者DBE未发现任何病变,包括2名经口和经肛DBE检查患者(均未完成全小肠检查),1名只行经口DBE检查,另外3名只行经肛DBE检查。所有未明确诊断患者由于持续性的症状转诊至外科接受腹腔镜或剖腹探查术。5名患者术后证实GIMTs向肠腔外生长,1名只接受经口DBE检查患者术后证实GIMT位于回肠。
绝大多数GIMTs患者经由DBE检查并明确诊断。绝大多数GIMTs内镜表现为小肠单发病变,向肠腔内突起。最常见的小肠GIMTs其粘膜表面常常是不光滑的,表现为糜烂或溃疡的外观。GIMTs第二种常见的内镜特点为肠腔肿瘤具有光滑的小肠粘膜,表现为卵圆形或椭圆形的宽基肿物。罕见有GIMTs内镜表现为不规则形状。
本研究中,术后病理证实的小肠GIMTs包括小肠间质瘤(gastrointestinal stromaltumor, GIST)(60例)、平滑肌瘤(6例)、脂肪瘤(3例)、血管瘤(3例)、淋巴管瘤(3例)、纤维组织细胞瘤(1例)、血管肉瘤(1例)。基于肿瘤原发部位,所有GIMTs经手术和术后病理证实均是小肠原发肿瘤。两种类型的GIMTs在本研究中被发现,包括腔内型和腔外型肿瘤,其中腔内型GIMTs最常见且由手术证实。除2名患者为小肠多发淋巴管瘤,余下所有患者均为单发肿瘤性病变。且本研究发现,GIMTs最常见部位位于空肠(60例),其次见于回肠(16例),较少见的部位是十二指肠(1例)。术后证实所有GIMTs并未发生周围浸润、远处转移和扩散。
所有小肠GIMTs患者接受治愈性切除,病变切除后临床症状消失,患者自觉明显改善。所有患者术后接受平均14.5个月电话随访,所有患者并无与DBE和手术相关报道。
4.CE与CTE/MRI对可疑或已确诊的SBDs诊断价值的系统评价
4.1CE与CTE对可疑/已确诊SBDs诊断比较
本研究纳入15篇文献,8个研究采用CTEc,7个研究采用CTEg。所有研究CE均采用以色列Given公司CE系统。
15篇文献纳入475名个体,包括4篇回顾性研究。所有研究均报告CE与CTE对SBDs的诊断阳性率。合并结果显示,CE在SBDs的诊断上优于CTE (OR=1.94,95%CI1.03-3.65;P=0.039),主要是与CTEc比较(OR=2.94,95%CI1.42-6.09;P=0.004),对于CTEg来说,CE并不占有优势(OR=1.20,95%CI0.45-3.22;P=0.714)。由于异质性检验发现合并研究间存在统计学差异(χ2=19.8;P<0.001,I2=75.0%),因此采用随机效应模型。
4篇文献纳入OGIB患者比较CE和CTE的诊断效能,共纳入114名患者。合并结果显示CE和CTE对于OGIB患者诊断效能相当(OR=1.20,95%CI0.71-2.05; P=0.50)。异质性检验无统计学差异,因此采用固定效应模型(χ2=3.51;P=0.319,I2=14.6%)。
9篇文献纳入241名可疑和已确诊CD患者对CE和CTE进行比较,其中7篇文献纳入已确诊CD患者。合并结果显示,CE总体来说在可疑和已确诊CD患者诊断上优于CTE (OR=2.77,95%CI1.24-6.17; P=0.013),但主要是与CTEc比较(OR=4.11,95%CI1.88-8.97;P<0.001),在与CTEg比较上,两者诊断效能相当(OR=2.16,95%CI0.71-6.61;P=0.176)。异质性检验发现存在统计学差异,因此采用随机效应模型(χ2=22.84;P<0.004,I=65.0%)。
纳入研究中有4篇文献比较CE与CTE对可疑和已确诊SBTs诊断价值比较。合并结果显示,CE和CTE对可疑和已确诊SBTs具有相似的诊断阳性率(OR=0.4,95%CI0.03-4.92;P=0.48),异质性检验存在统计学差异,因此采用随机效应模型(χ2-7.9; P=0.019,I2=74.7%)。
在检测发表偏倚的过程中,统计学异质性存在于CE与CTE对SBDs总的诊断阳性率比较、可疑和已知CD诊断阳性率比较、可疑和已知SBTs诊断阳性率比较,对OGIB患者的比较中并未发现存在异质性。漏斗图评估并未发现明显的不对称,Egger's and Begg's tests也并未检测到明显的发表偏倚(Egger's test:P=0.502)。敏感性分析基于研究设计,排除4篇回顾性分析文献后,其总的合并结果并未发现明显改变。
4.2CE与MRI对可疑/已确诊的SBDs诊断比较
本研究纳入17篇文献,7篇文献纳入已知SBDs的研究受试者,6篇文献纳入可疑和已确诊SBDs的研究受试者,余下的文献纳入可疑SBDs研究受试者。
17个研究纳入526名可疑和已确诊SBDs个体比较CE和MRI的诊断阳性率。异质性检验χ2=52.01; P<0.001,I2=69.2%;因此采用随机效应模型。合并结果显示CE在对可疑和已确诊的SBDs诊断上并不优于MRI (OR=1.51,95%CI0.89-2.56;P=0.127).亚组分析表明CE与不同方式MR诊断效能也是相当的,无论是MREg (OR=1.53,95%CI0.83-2.84;P=0.174)还是MREc (OR=1.02,95%CI0.37-2.86; P=0.963).
4个研究针对CE和MRI对OGIB患者的诊断阳性率比较。合并OR值(OR=3.88,95%CI1.83-8.23; P<0.001))表明,在以OGIB为症状的可疑SBDs患者中,CE在诊断阳性率上明显优于MRI。异质性检验并无统计学意义(x2=3.21;P=0.36; I2=6.7%)。
8个研究纳入可疑和已确诊CD患者并对CE和MRI进行比较。合并结果显示两种检查手段的诊断效能相当(OR=0.92,95%CI0.44-1.93; P=0.832)(χ2=16.15; P=0.024;I2=56.6%)。
7个研究纳入可疑和已确诊SBTs患者比较CE和MRI的诊断效能,其中五个研究纳入已知家族性腺瘤息肉病(known familial adenomatous polyposis,FAP)患者或黑斑息肉病(Peutz-Jeghers' syndrome, PJS)患者。合并结果显示CE和MRI在诊断可疑和已确诊SBTs并无明显差异(OR=1.30,95%CI0.47-3.55; P=0.614)。由于存在统计学异质性,因此,采用随机效应模型(heterogeneity χ2=9.57; P=0.048;I2=58.2%)。
结论
1.结合国内其他研究结果,本研究结果在一定程度上再次证实了中国人群的SBDs特点,炎症性／感染性疾病、原发性小肠肿瘤和小肠肠管畸形是当前单中心人群研究最常见的小肠病变；进一步来说,DBE在本研究的应用再次证实DBE是一种安全、有效的诊治可疑SBDs的内镜手段,即使是一种侵袭性检查,但DBE能提供病变的相对准确部位并能进行某些治疗性操作,可以在临床实践中广泛推广和应用；基于国内SBDs诊治现况,我们提出一个适合中国人群应用可疑SBDs诊断流程以供临床实践参考。
2.CE和DBE对发现小肠糜烂／溃疡性病变,特别是多发病变,病变检出率较高,且一致性较好；但CE检查前需确认小肠有无严重狭窄,且CE所见病变并非都是可信的；
3.DBE对小肠病变常规活检阳性率较低,对于DBE检查时发现病变,特别是溃疡性病变,建议除常规病理学检查外,免疫组织化学检查作为常规检查,便于排除可能存在的恶性病变,因为内镜活检的常规病理也并非都可信。
4.对于高度可疑的MD患者,特别是有症状的男性患者,相对于CE,DBE是一种更有效的、可靠的检查手段,基于解剖学的考虑,经肛DBE检查是一种具有较高的诊断准确性的插镜途径。阴性的Meckel's scan不能排除MD的存在,进一步来说,阴性的CE结果也不能排除重要小肠病变的存在,当高度可疑小肠病变时,即使在CE阴性的情况下,DBE也是必要的。
5.对于内镜发现MD,无论是否出现并发症,只要无手术禁忌症,建议治愈性切除(手术／内镜)；提出小肠可疑憩室诊断流程供临床实践所参考。
6.DBE对于小肠GIMTs的病变检出率明显优于CE,还可在镜下进行标记,能为后续手术切除病变提供精确的定位；对于DBE发现可疑小肠间叶组织肿瘤,在无法保证内镜切除成功的情况下,建议不做活检,仅作标记。
7.小肠GIMTs内镜常表现为小肠单发病变,并突向肠腔。最常见的GIMTs其粘膜表面常常是不光滑的,表现为糜烂或溃疡的外观；其次是具有光滑的小肠粘膜,表现为卵圆形或椭圆形的宽基隆起肿物；罕见有内镜下表现为不规则形状。
8.CE对可疑SBDs诊断上优于CTEc,并不优于CTEg;对OGIB患者和可疑／已确诊的SBTs/CD患者,当前研究表明CE在诊断效能上并不优于CTE；除了CE对OGIB患者的诊断阳性率优于MRI外,无论是在SBDs总的诊断效能还是对可疑／已确诊的CD/SBTs患者,其CE诊断价值与MRI相当。CE与CTE/MRI起着相互补充的作用具有更大应用价值和临床意义。
Background
Small bowel (SB) is the longest part of entire gastrointestinal tract and considered as a blind spot in the past because of limitations of traditional methods such as push enteroscopy (PE) and colonoscopy. Conventional endoscopes can be performed to investigate proximal SB and terminal ileum, respectively. Small bowel diseases (SBDs) has low prevalence and nonspecific manifestations, plus deep location in the digestive tract, the diagnosis and treatment of patients with SBDs may be delayed, contributing to huge medical cost and poor prognosis. Early identification, diagnosis and timely intervention of SBDs become extremely important in clinical practice. With advent of capsule endoscopy (CE) and balloon-assisted enteroscopy (BAE), patients with SBDs can be early diagnosed and treated by theses advanced techniques with endoscopic biopsy(BAE), their application innovates a new era for diagnostics and management of SBDs.
CE, also known as wirelesses CE, was initially invented and developed by Given Image Corp. at the beginning of this century. Compared with traditional noninvasive methods such as small bowel barium study and CT, CE can be performed to investigate the entire SB according intestinal movements because of its characteristics of noninvasiveness, non-radioactive hazard, higher detection rate and fewer complications. Currently, CE has been widely used in clinical practice. The findings of numerous clinical trials showed that CE has high diagnostic yields in patients with suspected SBDs, obscure gastrointestinal bleeding (OGIB), suspected/ known small bowel tumors(SBTs), suspected/known Crohn's diseases (CD).
Double-balloon enterosocopy (DBE) was firstly reported in2001and applied into clinical practice in2003. Compared with traditional invasive PE, DBE with two balloons at the end of the overtube and the enteroscopy overcomes the shortcomings of length of PE, which can be operated to grip the intestine by inflating the balloon so as to insert into distal SB. In addition, DBE can be performed by endoscopist back and forth to conduct biopsy, positional mark and therapeutic management. Similarly, a lot of clinical trials have confirmed that DBE has high diagnostic yields in patients with suspected SBDs, OGIB, SBTs, CD and has excellent safety in clinical practice. Currently, DBE can be not only used to investigate the SB, but also performed to investigate the upper gastrointestinal tract, the lower digestive tract, biliary tract and altered gastrointestinal anatomy. The application of DBE is a major progress of endoscopic technology development in the21st century.
Meckel's diverticulum(MD) is the most common congenital malformation in the gastrointestinal tract, which is a true diverticulum. Epidemiological studies show that MD occurs in less than2%of the population and more common in men, which is divided into symptomatic MD and asymptomatic MD. Symptomatic MD is frequently found in childhood and the aldults, and asymptomatic MD may not be examined during the lifetime of patient with MD. Although it is rare, complications of MD may lead to uncontrolled hemorrhagic shock arising from acute gastrointestinal bleeding, serious infectious peritonitis from intestinal perforation, intestinal obstruction/intussusception, etc. Currently, preoperative diagnosis of MD is relative low and MD is found incidentally by surgical exploration. There are few reports regarding to diagnosis of MD by DBE or CE although the both methods have been used to be compared each other in patients with OGIB, suspected CD and SBTs. As far as comparative diagnosis of patients with MD is concerned, there is lack of clinical study for comparison between CE and DBE.
Gastrointestinal mesenchymal tissue tumors (GIMTs), including myogenic tumors, neurogenic tumors and gastrointestinal stromal tumor (GISTs), account for less than10%of gastrointestinal tumors. Radiological imagings(such as barium study, computed tomography(CT) and angiography) is usually performed to examine small bowel GIMTs without the application of CE and double-balloon enteroscopy (DBE). Barium study is feasible for diagnosis of biggish intraluminal SBTs; CT is used to locate the lesion, assess for invasion and detect metastasis of SBTs. GIMTs are common in the different part of SB. Their true incidences might be higher than those studies reported previously because novel methods such as CE and BAE are much more sensitive and specific in diagnosing GIMTs than conventional methods. Several studies indicated that DBE is a safe and effective procedure that enables accurate diagnosis of SBTs. To date, few studies have reported the diagnosis of GIMTs by DBE and elucidated their clinical and endoscopic features. Furthermore, rare studies have compared diagnosis of GIMTs by DBE and CE.
The application of CE poses a significant challenge on conventional radiological examinations. Moreover, number of publications and experts suggested that CE should be a first-line tool for diagnosis of SBDs because of its advantages of invasiveness and higher diagnostic yield when compared with traditional methods. Even so, radiologic imaging still plays an important role in the diagnosis of patients with suspected/established SBDs. CT has become a widely used technique for examining the SB in recent years, either by CT enteroclysis(CTEc)or by CT enterography(CTEg). The role of CTE in the diagnosis of SBDs has been gradually expanded and evolving with recent technical advances of spiral and multidetector row CT (MDCT) technology. CTEc overcomes the individual deficiencies of both barium enteroclysis and conventional CT and combines the advantages of both into one technique whose clinical applicability has been simplified and made more reliable with spiral and MDCT. Number of clinical trials suggested that this technique is reliable method in the diagnostics of SBDs due to its characteristics of well-tolerance and easy to perform, either for suspected/known SBTs or for suspected/established Crohn's disease (CD). CTEg was first described by Raptopoulos et al, which is an noninvasive peroral method of evaluating the SB by obtaining good distention and combines the improved spatial and temporal resolution of CT with large volumes of ingested enteric contrast material to permit visualization of the SB wall and lumen. Following studies revealed that CTEg is an accurate diagnostic imaging for SBDs, including luminal and extraluminal pathology. Magnetic resonance imaging (MRI) technique has also evolved as a powerful tool in recent years and is playing an increasing role of in the evaluation of SBDs, especially application of MR enteroclysis/enterography (MREc and MREg). Strengths of MRI include the superior soft-tissue contrast, lack of ionizing radiation, and the implementation of fast scanning techniques. Furthermore, both extraluminal and intraluminal abnormalities can be investigated through cross-sectional imaging. And that adequate luminal distention is achieved by MRE, combined with contrast enhancement and functional information, help to make an accurate diagnosis. Several studies have shown the advantages of this technique over traditional enteroclysis due to improvements in spatial and temporal resolution combined with improved bowel distending agents. Currently, there are still controversies in the diagnosis of SBDs between CTE/MRI and CE. Firstly, the findings of a crowd of clinical trials and perspectives proposed by experts suggested that CE should be the first-line tool for evaluation of suspected SBDs due to its higher yield when compared with other traditional modalities, excellent safety and rare complications. However, other studies showed that CE has a low yield for evaluation of suspected SBDs in patients with abdominal pain or diarrhea and cannot be recommended as a first-line test without further study. But it facilitates diagnosis in9%of patients with negative endoscopic and radiologic examinations. Secondly, some experts suggested that the diagnostic value of MRE and CTE is sufficient for clinical management of most patients with suspected SBDs, and thus CE may be omitted or at least postponed for later usage. CTE and MRE should be the first-line modality in the imaging of CD and is considered the most appropriate imaging modality in patients with suspected CD. The third point of view is that CE detects more SB lesions and is greatly superior to CTE/MRE for diagnosing SBDs, CE plays a major role and CTE/MRE only acts as a complementary and selective role. Fourthly, the three modalities play complementary role in the diagnostics of SBDs. As three different kinds of alternative modalities in clinical practice, CTE/MRI and CE are performed to compare their diagnostic yield of SBDs because there is still debatable problem. However, the results from clinical trials are inconclusive and contradictory. To date, there is no meta-analysis published to compare these methods and evaluate the diagnostic yields. To assess diagnostic efficiency of the these modalities for investigation of SBDs, we undertook a meta-analysis of studies that reported head-to-head comparison of diagnostic yield between CTE/MRI and CE.
Objectives
1. To retrospectively analyze the data of patients who underwent DBE from a single center with nine year's experience, and elucidate the characteristics of SBDs in a single-center Chinses population;
2. To retrospectively analyze the observational data collected from patients who underwent examination with CE, DBE, or both to evaluate DBE in the diagnosis of MD and to compare its diagnostic yield with that of CE.
3. To retrospectively analyze the data collected from patients who underwent examination with DBE, CE, or both to evaluate DBE in the diagnosis of GIMTs and to compare its diagnostic yield with that of CE.
4. To compare diagnostic performance of CE, CTE and MRI in patients with suspected SBDs based on evidence-based medince.
Materials and Methods
Department of Gastroenterology, Nanfang Hospital in Guangzhou is one the earliest endoscopic unit with introduction of small bowel endoscopy in China. DBE system was introduced in2003and domestic OMOM CE system was introduced in2005.
1. DBE for diagnosis of suspected SBDs:nine-years' experience from a single-center
A retrospective analysis was conducted from the data of patients who underwent a DBE procedure in a single-center with nine years' experience in China (from2003to May2012), including collection of demographic data, other inspections prior to DBE procedure, indications for DBE, positive biopsy rate, management after DBE examination.
2. DBE and/or CE for diagnostic value of MD
The current study was to assess the value of DBE in the diagnosis of MD and comparatively evaluate the diagnostic yield of DBE and CE for MD. A single-center study was performed on patients with a confirmed diagnosis of MD by surgery and postoperative pathology between January2003and December2011. A follow-up was conducted as well.
3. DBE and/or CE for to diagnosis of GIMTs, and analysis of clinical and endoscopic features of GIMTs
A retrospective review in a total of783patients who underwent a DBE procedure from January2003to December2011was conducted. Data from patients with pathologically confirmed GIMTs were analyzed at a single tertiary center with nine years'experience. The primary outcomes assessed included characteristics of patients with GIMTs, indications for DBE, overall diagnostic yield of GIMTs, endoscopic morphology, positive biopsy, comparison of diagnosis with CE, and subsequent interventional management.
4. Systematic review and meta-analysis for diagnosis of suspected/known SBDs between CE and CTE/MRI
Based on computer-aided strategy, we searched electronic database Medline (January2001-November2012), EMbase (January2001-November2012), Cochrane central register of controlled trials (January2001-November2012), Web of Knowledge (January2001-November2012). Abstracts published in international conferences and potential literatures were performed by manual search. Studies regarding head-to head comparison CE with CTE/MRI were included. Main outcomes assessed inlucded diagnostic yield of CE CTE/MRI, the second outcomes evaluated were diagnostic yields of suspected/confirmed CD, suspected/confirmed SBTs, and patients with OGIB.
Statistical analysis
Data analysis of retrospective study was performed by statistical software SPSS version17.0for Windows. Continuous data were presented as means, mean±SD or range, and categorical variables were expressed as frequency or percentages. The x2 test or Fisher's exact probability test was used to compare differences in categorical variables examined. Agreement analysis was assessed by the Kappa statistic:a kappa value<0.4indicates poor agreement, between0.4and0.7indicates moderate agreement, and>0.7indicates good agreement. McNemar'sχ2test (namely pairedχ2test) was used to compare the diagnostic yields between CE and DBE. A P value<0.05(two-sided) was considered statistically significant.
The software STATA/SE version11.2(Stata, College Station, TX) was used to conduct statistical analysis of data synthesis and analysis. Effect size for pooled discontinuous variables was expressed as odds risks (ORs) and mean difference with95%confidence interval (95%CI). P value<0.05was considered statistically significant. The heterogeneity cross studies was evaluated by calculating the I2statistic of inconsistency with a cutoff point of I2=50%. And then random effect model was used when I2statistic>50%and P value<0.05. Publication bias was evaluated by funnel plot and examined by the Egger's and Begg's tests. Subgroup analysis was conducted on the basis of CTEc and CTEg, MREc and MREg. Sensitivity analysis was conducted based on the study design.
Results
1. Nine years' experience of DBE application in patients with suspected SBDs at a single center
A total of825patients underwent DBE investigation, with mean age41.3±16.3years (range8-84years). Male accounted for71.3%of all the patients. Obscure gastrointestinal bleeding(OGIB) was the most common indication for DBE investigation, accounting for50.2%(39.2%of overt-OGIB and11.0%occult-OGIB, respectively), followed by abdominal pain (36.8%), abdominal distention (3.8%), patient's requirement for screening (3.8%), diarrhea (2.4%), vomiting (1.7%), debilitation(0.8%), weight loss(0.5%).
Blood test, defecate convention examination (including fecal occult blood testing), ECG, abdominal X-ray and abdominal ultrasound were regularly performed in the patients registered in our care unit. Each patient received at least one kind of other medical examination, including colonoscopy (80.7%), gastroscopy (79.0%), computed tomography (CT)(23.5%), barium study (20.1%), Meckel's scan (8.1%), angiography (4.8%), bone marrow aspiration (3.0%), push entroscopy(2.5%), magnetic resonance imaging (MRI)(2.2%). Patients with confirmed diagnosis were not obtained by above examinations.
262patients received CE examination; two of them receive CE after DBE procedure beyond duration of two weeks and has no diagnosis by CE.260of them patients received CE prior to DBE within an interval of two weeks. CE identified lesions/suspected lesions in187patients, definite diagnosis was finally determined in150patients (57.7%). Complications occurred in17patients (6.5%), including incomplete intestinal obstruction (1case), incomplete entire SB examination because of CE with running out of charge (1case), timely reconnection after disconnection of the CE data line (1case), CE retention (14cases). CE retention primarily occurred in patients with intestinal ulcers and stricture (13cases).260patients who received tandom CE and DBE,188of them were definitely diagnosed by DBE. Comparison of diagnostic yield between CE and DBE was seen in Table1.
*P=1.000.
A total of825patients underwent1159DBE procedures, including antegrade approach for294patients, retrograde approach for231patients and combination of the two approaches for300patients. Total enteroascopy (antegrade approach alone or antegrade+retrograde approachs) was achieved in120patients (14.5%).
368patients with SBDs were identified by antegrade DBE, with44.6%of lesion detection rate;284patients with SBDs were identified by retrograde DBE, with34.4%of lesion detection rate.385patients received endoscopic biopsy, positive biopsy was achieved in54of them and the positive biopsy rate was14.0%.
602patients with lesions (with73.0%of lesion detection rate) were detected by DBE, including missed lesions in the stomach and the colon in5cases (0.6%) and11cases (1.3%), respectively.552patients with SBDs were definitely diagnosed by DBE, and the diagnostic yield was66.9%. Finally,624patients with confirmed diagnosis had gastrointestinal lesions based on following management, including608patients with SBDs. Inflammatory/infectious diseases were the most common findings of SBDs, with a proportion of50.2%. Next was primary SB tumor (SBT)(20.2%), followed by abnormalities of intestinal tube (16.0%), vascular lesions (5.1%), metastatic intestinal tumor (1.5%), other miscellaneous lesions (7.1%).
Based on confirmed location of lesion, intestinal lesions were most frequently detected in the ileum (25.5%), followed by the jejunum (24.6%), multiple parts of the SB(16.7%), duodenum (5.6%).
Patients with confirmed SBDs received medical treatment such as pharmacotherapy, endoscopic intervention (tissue sampling, homeostasis, CE retrieval (CE retrieval was successfully performed by DBE in8patients), polyp resection, and surgical procedure (275cases, including all patients with MD and SBTs). Three patients underwent intraoperative endoscopy (including1case with Bean syndrome,
2cases with acute massive gastrointestinal bleeding).
Five patients occurred adverse events during and after DBE procedures. Intestinal perforation arised from MD with ulcer was recorded in one case after retrograde DBE and was verified by surgical procedure. Two patients had mild pancreatitis after oral DBE procedures and received conservative therapy. Rupture of a balloon equipped with the overtube was reported in two patients during the antergrade and the retrgrade procedure, respectively, patients with discomfort was not recorded. The patients completed DBE investigation after a new overtube was equipped. A few patients complained of mild laryngeal discomfort after the peroral approach, without special treatment.1patient died from acute massive hemorrhagic shock because the casue of hemorrhage was not found by intraoperative DBE. Another patient died from other diseases.
2. DBE and/or CE for diagnosis of MD
A total of783patients underwent1071DBE procedures for diagnosis or interventions of gastrointestinal diseases. Of these patients, a definite diagnosis of MD was established in74inpatients by surgery and postoperative pathological examination after DBE. With a mean age of29.0±14.3years (range,8±76years), the patients underwent DBE mainly for melena/hematochezia (64cases), abdominal pain (8cases), or diarrhea (2cases). Of the74MD patients,26patients also underwent CE before DBE. Some patients had previous examinations with a gastrointestinal barium study (15cases), computed tomography (12cases), digital subtraction angiography (6cases), or magnetic resonance imaging (2cases) before admission into our center.
A total of26patients received a traditional Meckel's scan before and after both methods. It was performed in20patients before CE and/or DBE and yielded negative results in14cases, suspected diagnosis of MD in3cases, and definite diagnosis of diverticula in3cases. After CE and/or DBE, Meckel's scan was used in6patients and yielded positive results in5cases.
All74patients successfully completed the preoperative DBE procedure. Only one patient complained of persistent abdominal pain and intermittent vomiting after DBE, which was found to result from acute peritonitis caused by diverticulum perforation, as confirmed by subsequent surgery. One patient underwent an endoscopic intervention for hemostasis. Compared with the operative and pathologic diagnosis, preoperative DBE showed a diagnostic yield of DBE of86.5%(64/74) for MD.
Six patients underwent DBE via the peroral approach, which resulted in clear diagnoses of MD in4cases, one without lesion and one with overt massive bleeding in the ileum. Forty-five patients underwent DBE via the peranal approach, and only5had definite diagnoses other thanMD, including3with suspected gastrointestinal stromal tumors (GISTs), one with misdiagnosed intestine duplication, and another without lesions because of massive bleeding. The remaining23patients were examined with a combination of both approaches, and total enteroscopy was successfully completed in10patients. The combined approaches resulted in the diagnosis of MD in20cases (all found via a retrograde approach), detected overt bleeding in1case (via a combined approach), and identified no obvious lesions in2cases.
In the10patients with no definite diagnoses or misdiagnoses by DBE, open or laparoscopic surgeries were carried out for removal of the suspicious masses (GIST) in3cases, intestine duplication in one case, and emergency surgery was performed in1case for perforation of the diverticulum. The other5patients underwent subsequent Meckel's scintigraphy, and a suspected diagnosis of diverticulum was made in4patients, who then received exploratory laparotomy to locate the site of gastrointestinal bleeding. Inverted MD initially misdiagnosed as GISTs by DBE in3cases was finally confirmed by an operative procedure and pathology.
Operative and pathologic findings demonstrated that single diverticulitis was the most common pathology in the MD lesions (40.5%), followed by diverticulum with concurrent ectopic gastric mucosa (31.1%), diverticulitis associated with ulcer (20.3%), diverticulum with ectopic gastric mucosa and pancreatic tissues (5.4%), and diverticulum with heterotopic pancreatic tissues (2.7%).
All26patients undergoing both CE and DBE procedures completed the examinations successfully. CE was easily swallowed and excreted by the patients without any complications, as confirmed by X-ray. In one case, the data line of CE was disconnected from the image recorder but soon reconnected. A total of37DBE procedures were performed in the26patients, and no patients complained of obvious discomfort during or after the procedure. The overall diagnostic yield of DBE for MD was84.6%, which was significantly greater than that of CE (7.7%, P<.000, McNemar'sx2test). Poor agreement was found between the findings of DBE and CE (kappa=0.03).
All patients received a range of1month to5years follow-up in the form of a telephone interview; the clinical symptoms disappeared after the operative procedure was performed. It was notable that4(3males and1female) were diagnosed as having small bowel Crohn's disease2years after surgery and received treatment in our center.
3. DBEand CE for diagnosis of small bowel GIMTs and characteristics of small bowel GIMTs
A total of77inpatients who underwent DBE were identified; their final diagnoses were confirmed as GIMTs by histopathology and/or surgery. The mean age was47.74±14.14years (range:20-77years), with63.6%being males. The majority of patients presented with GI bleeding, accounting for81.8%, followed by abdominal pain, accounting for10.4%.
All the patients underwent other medical examinations prior to DBE, including gastroduodenoscopy (73cases), colonoscopy (66cases), and push enteroscopy (1case), and yielded negative or suspected diagnoses. Barium study was conducted in10patients, only one patient was suspected of having a SBT. Twelve patients received CT scan, SBT was found in two patients and suspected SBT was found in one patient. Two patients were found to have suspected SBT by magnetic resonance imaging,2by angiography,3by Meckel's scan and2by bone marrow aspiration.
Thirty-one patients underwent CE examination before DBE within an interval of two weeks. All patients successfully completed CE procedures which reached the colon. Positive diagnoses were made in11patients, and suspected diagnoses in8 patients. No lesion was detected in12patients. No complications occurred during and after the procedure.Thirty-seven DBE procedures were performed in31patients, including22antegrade approaches,3retrograde approaches, and6combinations of the two approaches. The sensitivity of DBE and CE for the diagnosis of GIMTs was93.5%and61.3%, respectively. DBE for the diagnosis of GIMTs was superior to CE (P=0.006, McNemar's χ2test).
A total of93DBE procedures were performed in77patients, including49antegrade DBE approaches,12retrograde DBE approaches and16combinations of the two approaches. Total enteroscopy (TE) was achieved in3patients. Lesions were found in the small bowel in71patients, the detection rate for GIMTs being92.2%. Clear diagnosis was established in68patients, and the diagnostic yield of DBE for GIMTs was88.3%. Multiple tissue samplings were made in41cases; positive diagnoses were obtained in5cases. Only one therapeutic procedure was performed in one patient, i.e., a leiomyoma (8mm) was removed by DBE. All the patients successfully completed the entire DBE procedure, without any complications occurring during and after the procedure.
Among9patients with unclear diagnosis by DBE, one was found with overt, ongoing bleeding, and two were found with single ulcerative lesions in proximal small bowel, respectively. No abnormality was found in six patients, including two patients treated with the combination of the two approaches (neither completed TE), one with the antegrade approach, the other three with the retrograde approach. Patients with indefinite diagnoses underwent surgical procedures (laparotomy or laparoscopic exploration) because of persistent symptoms. Five patients had GIMTs with extraluminal growth confirmed by surgery; one patient undergoing the antegrade approach had a GIMT located in the ileum.
Endoscopic diagnosis was established in the overwhelming majority of the patients. Most GIMTs presented as a single lesion under the endoscopic view, protruding into the intra-luminal mass in the small bowel. The unsmooth surface of the tumor was seen most frequently, showing the appearance of erosion or ulcer. The second frequent morphology was a mass with smooth surface, indicating a tumor with sessile base in a rounded or oval shape. Rare GIMTs presented with irregular shapes under endoscopic view.
In this study, GIMTs with confirmed diagnoses included GIST (60cases), leiomyoma (6cases), lipoma (3cases), hemangioma (3cases), lymphangioma (3cases), fibrous histiocytoma (1case), and angiosarcoma (1case). Based on the primary sites of tumors, GIMTs in our study were all primary tumors verified surgically and pathologically. Two kinds of GIMTs were detected on the basis of site, including intra-and extra-luminal tumors. Intra-luminal GIMTs were detected most frequently and verified by endoscopy and surgery (Figures1,2). A single lesion was most frequently examined, except in two patients who had multiple lymphangiomas. GIMTs were detected most frequently in the jejunum (60cases), and next in the ileum (16cases) and duodenum (1case). No spread and metastasis was investigated and confirmed after surgical removal.
The findings of DBE changed the therapeutic plan and enabled all the patients to receive early intervention. The clinical symptoms disappeared after surgery and all the patients felt an improvement in their conditions. They received an average follow-up time of14.5mos after intervention, and important improvements were obtained in the patients after DBE and surgical intervention. No complication was reported.
4. Results of meta-analysis for comparison diagnosis of suspected/known SBDs between CE and CTE/MRI
4.1Results of meta-analysis for comparison diagnosis of suspected/known SBDs between CE and CTE
4.1.1Comparison of overall diagnostic yield between CE and CTE
15trials met the inclusion criteria,8of them performed CT enteroclysis, and seven of them performed CT enterography. CE used in the included studies was a product of Given Corp.15trials involved a total of475individuals, including4retrospective studies. All of included studies reported the diagnostic yield of comparison between CE and CTE. CE was superior to CTE in the diagnosis of SBDs (OR=1.94,95%CI1.03-3.65;P=0.039), mainly for comparison with CT enteroclysis (OR=2.94,95%CI1.42-6.09;P=0.004), not with CT enterography(OR=1.20,95%CI0.45-3.22; P=0.714). Random-effect model was used because significantly statistical heterogeneity was detected cross the studies (x2=19.8; P<0.001,12=75.0%), but with no evidence of funnel plot asymmetry(Egger's and Begg's tests, P>0.05, respectively).
4.1.2Comparison of diagnostic yield between CE and CTE in patients with OGIB
4studies reported diagnostic yields of CE and CTE in patients with OGIB, in total of114individuals. CE and CTE had comparable diagnostic yields in patients with OGIB (OR=1.2,95%CI0.71-2.05; P=0.50). No statistical heterogeneity was noted between studies (x2=3.51; P=0.319,I2=14.6%).
4.1.3Comparison of diagnostic yield between CE and CTE in patients with
suspected and established CD
9studies comparing CE with CTE involved in241subjects,7of which included patients with established CD. The pooled data indicated that CE was generally superior to CTE in the diagnosis of suspected and known CD (OR=2.77,95%CI1.24-6.17; P=0.013), mainly for comparison with CT enteroclysis(OR=4.11,95%CI1.88-8.97; P<0.001), not with CT enterography(OR=2.16,95%CI0.71-6.61; P=0.176), with statistical heterogeneity between studies(x2=22.84;P<0.004, I2=65.0%).
4.1.4Comparison of diagnostic yield between CE and CTE in patients suspected and established SBTs
4studies compared the yield of CE with CTE for the diagnosis of suspected and known SBTs. CE and CTE provided similar diagnostic yields in patients with suspected and known SBTs (OR=0.4,95%CI0.03-4.92; P=0.48), with significant heterogeneity cross the studies(x2=7.9; P=0.019,I2=74.7%).
4.2Results of meta-analysis for comparison diagnosis of suspected/known SBDs
between CE and MRI
4.2.1Comparison of overall diagnostic yield between CE and MRI
17studies (including three abstracts) were identified for comparison between CE and MRI in patients with suspected and established SBDs.7of included trials incorporated patients with known SBDs,6included patients with suspected and known SBDs, remains included patients with suspected SBDs.
17trials included526individuals for comparison CE with MRI in the diagnostics of suspected and established SBDs. Pooled analysis indicated that CE was not superior to MRI for diagnosis of SBD(OR=1.51,95%CI0.89-2.56; P=0.127). Statistical heterogeneity was detected between the studies (x2=52.01; P<0.001, I2=69.2%) and thus a random effects model was applied. Subgroup analysis indicated that CE had similar diagnostic performance compared with MREg (OR=1.53,95%CI0.83-2.84; P=0.174) or MREc (OR=1.02,95%CI0.37-2.86; P=0.963).
4.2.2Comparison CE with MRI in patients with OGIB
4studies were identified for comparison of diagnostic performance between CE and MRI. CE provided higher diagnostic yield than that of MRI in patients with OGIB. The OR was3.88(95%CI1.83-8.23;P<0.001). There was no significant heterogeneity cross the studies (heterogeneity x2=3.21; P=0.36; I2=6.7%).
4.2.3Comparison of CE and MRI in patients with suspected and established CD
8trials were identified to compare CE with MRI in patients with suspected and known CD. Both modalities yielded similar diagnostic performance (OR=0.92,95%CI0.44-1.93;P=0.832)(heterogeneity x2=16.15; P=0.024;I2-=56.6%).
4.2.4Comparison of CE and MRI in patients with suspected and established SBTs
7trials recruited patients with suspected/established SBTs for comparison CE with MRI. Five of them included individuals with known familial adenomatous polyposis (FAP) or with established Peutz-Jeghers' syndrome (PJS). Diagnostic efficacy of CE was not significantly different from that of MRI (OR=1.30,95%CI0.47-3.55; P=0.614). A random effects model was used because of statistical heterogeneity (heterogeneity x2=:9.57; P=0.048;I2=58.2%).
Conclusions
1. Combing previous reports from scatterd Chinese population, the current findings show that inflammatory/infectious diseases, pri
引文
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