经皮经肝穿刺胆道引流和支架置入术治疗恶性梗阻性黄疸短期降黄效果相关因素的分析
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摘要
研究背景
恶性梗阻性黄疸(Malignant Obstructive Jaundice, MOJ)是一组由胆管系统管腔内、外或管壁本身的恶性病变引起的胆管机械性阻塞,病原包括胆管癌、胆囊癌、原发性肝癌、壶腹癌、胰头癌及肝门区、胰腺区转移癌等,常造成阻塞远端的胆管扩张,可伴有胆道感染。胆管梗阻后引起毛细胆管扩张,伴随微绒毛消失和细胞间连接改变,使毛细胆管通透性增加,导致胆汁成分反流入血液和淋巴液。另外,胆管梗阻可引起肝细胞膜极性发生改变,很多酶和转运器从毛细胆管面转移至窦面和侧面,使得部分已进入肝细胞的胆汁成分重新分泌到血液。胆红素返流入血液,发生阻塞性黄疸、继而肝功能衰竭成为患者致死的主要原因。
一般来说,恶性梗阻性黄疸的外科手术治疗仍是目前最重要和根治的方法。手术的方法主要为切除病变、胆管改道引流。但恶性梗阻性黄疸被发现时已多属晚期,能行外科根治术者仅占7%,姑息性胆肠吻合术也仅适用于19%的病例。对于不能手术治疗的患者,黄疸可直接导致患者死亡,据统计平均生存期不足3个月。由于皮肤严重黄染、瘙痒、并发胆道感染、腹胀和消化不良综合征,其生活质量也随之下降。在这种情况下有效持续的胆道引流减黄是首要的治疗措施,可以延长患者生存期和提高生活质量,并为进一步的抗肿瘤治疗打下基础。其中,经皮经肝胆道外引流术、内外引流术和胆道支架置入术是恶性阻塞性黄疸简易有效的微创治疗技术。相比以往手术治疗,现在患者只需要适当的镇静即可进行手术,且术后只需要很短的住院时间。近年来,由于介入治疗方法和器材的不断进步,使其取代了部分外科手术疗法,或成为外科手术前、后的重要协助手段。介入治疗恶性梗阻性黄疸,为一种姑息性治疗手段,着重于胆道系统的再通,对于减轻梗阻所致的黄疸、提高患者晚期生存质量、延长生存时间等方面有着重要意义。
经过60年的发展,经皮经肝穿刺胆道引流术(Percutaneous Transhepatic Biliary Drainage, PTBD)和支架置入术(Percutaneous Transhepatic Biliary Stenting, PTBS)在技术、材料等方面日臻完善,以其降黄效果好、并发症较少、病人痛苦少,已成为姑息治疗恶性梗阻性黄疸的最主要治疗方式。
PTBD和PTBS治疗MOJ可达到很好的降黄效果。但在临床工作中发现,PTBD或PTBS术后尤其是术后短期内胆红素下降的程度常存在较大的差异,甚至存在降黄效果不明显的情况。因此,除了基本技术、材料原因外,应尚存在其他的影响因素。
根据临床经验、胆管疾病的发病特点以及相关文献,本研究通过对影像学、化验指标、疾病情况、治疗情况和并发症等一系列可能与降黄效果有关的因素进行了比较全面的分析,探讨影响降黄效果的主要因素。
目的
探讨PTBD和PTBS治疗恶性梗阻性黄疸1周和1个月总胆红素下降情况及影响降黄效果的相关因素分析。材料与方法
2005年5月～2009年6月恶性梗阻性黄疸患者111例,男71例,女40例。年龄20-82岁,平均61.6±13.6岁。导致梗阻性黄疸的肿瘤分别为胆管癌52例(46.8%)、胰腺癌22例(19.8%)、胆囊癌6例(5.4%)、肝癌8例(7.2%)、壶腹周围癌7例(6.3%)、胰头转移癌7例(6.3%)、肝门转移癌9例(8.1%)。所有病人术前行详细的临床评价,包括病史采集、体格检查、超声或CT、MRI例检查和肝功能、血常规等化验分析。所有患者术前总胆红素(Total Bilirubin，TB)均大于60umol/L。
所有患者行PTBD或PTBS,根据不同情况行外引流管、内外引流管和金属裸支架置入治疗。
记录性别、年龄、术前胆道扩张程度、梗阻部位、狭窄段长度、Bismush分型、单双侧引流方式、治疗方法、病因、黄疸时间、术前胆管炎、梗阻程度、术前TB、术前IB/TB、术前肝功能、术后1周并发感染、术后并发胆道出血、术后1月存在感染等18项可能与降黄效果相关的指标。
降黄疗效判断：以总胆红素(Total Bilirubin, TB)的下降程度进行疗效判断。(1)、1周降黄效果：以1周TB下降比例了解不同因素对降黄效果的影响。行Logistic回归分析时,设定二分类降黄效果为结局变量,参考田伏洲等的降黄标准,以术后1周内总胆红素相对术前下降≥30%,并且临床观察皮肤、巩膜黄染逐渐减轻者为效果显著。否则,为效果欠佳(包括无效的患者)。(2)、术后1个月降黄效果：以术后1月TB值了解不同因素对1月降黄效果的影响。行Logistic回归分析时,以术后1个月时总胆红素是否下降至正常水平设定二分类结局变量。
应用SPSS13.0统计软件对数据进行统计学处理。采用配对样本t检验和基本频数分析,了解术后1周降黄效果和术后1月降黄成功率。再用Logistic回归分析筛选与降黄效果有关的变量。
结果
所有患者成功进行PTBD或PTBS,根据不同情况行外引流管(16例,14.4%)、内外引流管(55例,49.6%)和金属裸支架(40例,36.0%)置入治疗。共置入外引流管27根、内外引流管74根、金属裸支架53支。3例(2.7%)术中或术后出现胆道出血,32例(28.8%)术后并发化脓性胆管炎,18例(16.2%)术后出现败血症。术后未出现急性胰腺炎、急性肾功能衰竭等急重并发症。
1、术后1周降黄效果：全组患者平均总胆红素由术前的278.21±153.67umol/L降至术后一周的156.80±114.7umol/L,降幅达121.41±107.70umol/L;直应胆红素由术前的201.91±111.62umol/L降至117.90±87.40umol/L,降幅为84.01±75.48umol/L;间应胆红素则从76.30±55.63umol/L降至术后的38.90±37.41umol/L,降幅为37.40±48.01umol/L。统计学处理显示显著性差异(P<0.001)。总胆红素下降(42.0±30.5)%,效果显著者79例(71.2%)。
术后1月降黄效果：47人在PTBD或PTBS术后1月进行随访复查,总胆红素、直应胆红素和间应胆红素均较术前有较大的降幅,下降75%左右,下降至较低的水平。47例患者中总胆红素降至正常的患者有9例(19.1%)。
2、各因素的初步分析
初步分析影响1周降黄效果的因素有：术后1周并发感染(F=3.215,P=0.044)和术前肝功能(t=-1.994,P=0.049)。影响术后1月降黄效果的因素有：治疗方法(F=4.021,P=0.025)、黄疸时间(r=0.422,P=0.003)、术后1月感染情况(t=-2.269,P=0.028)、梗阻程度(t=3.665,P=0.001)、术前肝功能(t=-3.840,P<0.001)和术前TB(r=0.363, P=0.012)。
3、Logistic回归分析
1周降黄效果logistic回归方程的统计结果分析：logistic回归模型有统计学意义(x2=4.156,P=0.041)。方程拟合度尚可,Negelkerke R2为0.150。参数估计结果为：术后D7并发感染的MOJ的1周降黄效果较未并发感染的效果差(OR=0.552,95%CI为0.315～0.968)；梗阻部位中非肝门区MOJ的降黄有效率较高,为肝门区MOJ的2.653倍(OR=2.653,95%CI为0.988～7.121)；术前TB越高,术后黄疸下降速度越快(OR=1.004,95%CI为1.000～1.007)。
1月降黄效果logistic回归方程的统计结果分析：logistic回归模型有统计学意义(x2=10.217,P=0.001)。方程拟合度尚可,Negelkerke R2为0.437。参数估计结果为：梗阻部位中非肝门区MOJ的1月降黄成功率较高,为肝门区MOJ的13.706倍(OR=13.706,95%CI为2.087～90.030)；治疗方法中支架置入术(内引流)的1月降黄成功率最高,外引流最低(OR=4.574,95%CI为0.964～21.704)。
结论
(1) PTBD和PTBS治疗MOJ降黄效果明确,总胆红素、直应胆红素和间应胆红素在术后1周即下降42%,术后1个月下降75%左右。PTBD和PTBS治疗MOJ降黄成功率高,术后1个月即有19.1%的MOJ患者总胆红素下降至正常水平。
(2)术后并发胆道感染和败血症、术前肝功能C级是术后1周影响降黄效果的危险因素；非肝门区MOJ的降黄效果较肝门区MOJ的降黄效果好,术前TB较高的MOJ1周降黄效果可能更好。
(3)影响PTBD和PTBS术后1个月降黄成功率的因素有狭窄部位、治疗方法、术前肝功能、是否完全梗阻、术前TB、黄疸时间和术后1月感染情况。非肝门区、术前肝功能Child-Pugh B级、不完全梗阻、支架置入术后的MOJ术后总胆红素恢复正常的可能性大。术前黄疸时间长、术前TB值较高、术后1月仍存在感染的黄疸患者可能恢复较慢。
(4)虽然本组统计学分析显示：单双侧引流方式、并发胆道出血对PTBD和PTBS术后降黄效果无影响。但由于选择单双侧引流方式是在非随机对照的原则下进行,并发胆道出血的病例数较少,需进一步研究。
(5)术前胆管炎、Bismuth分型、术前IB/TB、狭窄段长度、胆管扩张程度、病因、性别、年龄对PTBD和PTBS术后短期内降黄效果无明显影响。
Background
Malignant obstructive jaundice (MOJ) is a group of mechanical bile duct obstruction due to malignant disease of the bile duct lumen and wall or the outer of bile duct, including cholangiocarcinoma, gallbladder cancer, hepatocellular carcinoma, ampullary carcinoma, pancreatic cancer and metastatic cancer, and so on. These tumors are often accompanied by blocking the proximal bile duct resulting in biliary tract dilatation and infection. Along with the obstruction, the inside pressure of bile duct and endothelial cell permeability increase and bilirubin enter into the blood, which can cause obstructive jaundice, sepsis, biliary cirrhosis, liver failure and hepatorenal syndrome, etc.
In general, surgery is still the most important and radical approach to treat malignant obstructive jaundice. Surgical approaches mainly include removal of lesions and surgical bile duct drainage. But malignant obstructive jaundice is found mostly when the tumors are on the advanced stage. Only 7% patients can suffer radical surgery and only 19% can be done by palliative biliary-enteric anastomosis. The incidence rate of postoperative complications and postoperative mortality are higher. For those patients with unresectable disease, progressive jaundice constitutes an immediate limitation to their survival and causes significant loss to their quality of life secondary to pruritis, malaise and cholangitis with the patients'average survival time less than 3 months. Effective and lasting decompression of the biliary tree is a priority therapeutic method including biliary drainage and placement of biliary stent. These procedures could be finished by these minimally invasive techniques: percutaneous transhepatic biliary drainage/stenting (PTBD and PTBS) and endoscopic retrograde biliary drainage (ERBD). Compared to surgery, patient can often be treated under moderate sedation with a short hospital stay.
In the last sixty years, the procedure of PTBD and PTBS has been progressing in skills and materials, and now has been the most important palliative technique in the treatment of MOJ because of its higher successful rate and better therapeutic effect comparing with ERBD.
PTBD and PTBS can reach a better relieving effect for MOJ. But in clinical, we found sometimes that PTBD and PTBS did not work as we expected, and the degree of palliation differed largely in these patients. So we thought there could be other influential factors.
Depending on clinical experience, characteristic of bile duct diseases and selected literatures, this study will discuss the influence factors of palliative effect of PTBD and PTBS from aspects of characteristic of imaging and chemical analysis, diseased and therapeutic conditions, and complications.
Objective
The purpose of the present study is to evaluate short-term palliative effect of PTBD and PTBS in MOJ, and to describe the influence factors of this palliative therapy.
Materials and Methods
111 cases of MOJ (,range 20-82 years, mean age 61.6 years) between May 2005 and June 2009 underwent clinical assessment. They were diagnosed as cholangiocarcinoma (n=52 cases,46.8%), pancreatic carcinoma (n=22,19.8%), gallbladder carcinoma (n=6,5.4%), liver cancer (n=8,7.2%), periampulllary carcinoma (n=7,6.3%), metastatic carcinoma of head pancreas (n=7,6.3%), metastatic carcinoma of hepatic hilum (n= 9,8.1%). Clinical analysis had been done in all cases through history-taking, physical examination, blood chemical and ultrasound or CT or magnetic resonance imaging examination. Serum total bilirubin exceeded 60 umol/L in 111 patients.
PTBD and PTBS was carried out in all patients, including 8.5F multi-lateral holes drainage tubes (COOK, USA) or bare metal stent (8mm or 10 mm diameter) placement.
Eighteen influence factors were recorded, which may be related to the palliative efficacy of MOJ, including perioperatively total bilirubin, direct bilirubin (DB), indirect bilirubin (IB), serum albumin (ALB), prothrombin time (PT), the degree of bile duct dilatation, location and length of stricture involving Bismuth type for hepatic hilar lesions, unilateral or bilateral drainage, the duration of jaundice, ascites, preoperative and post-operative suppurative cholangiti, bile duct bleeding after procedure, and so on. It is regarded as effective treatment that the total bilirubin decreased more than 30% on the 7th day after operation, based on Tian fuzhou palliative efficacy criterion. Multifactors analysis was done to explain whether the related factors affected the short-term palliative efficacy or not for MOJ after PTBD and PTBS.
Results
All patients underwent PTBD OR PTBS successfully with the success rate 100%. Twenty seven external drainage tubes (n=16,14.4%),74 internal and external drainage tubes (n=55,49.6%) and 53 bare metal stents (n=40,36.0%) were placed in bile ducts totally. Intraoperative or postoperative hemobilia were found in 3 cases (2.7%). Suppurative cholangitis happened in 32 cases (28.8%) and sepsis in 18 cases (16.2%). Acute pancreatitis, acute renal failure and other critical complications were not found in these cases.
(1) Palliative efficacy of one week (paired sample t test):preoperative total bilirubins (TB) were 278.21±153.67 umol/L, and postoperative total bilirubins were reduced to 153.80±114.7umol/L. There is statistically significant difference (P≤0.001) between TB and D7TB. Total bilirubin decreased (42.0±30.5)%, and it was effective in reducing of jaundice in 79 cases (efficient rate 71.2%).
Palliative efficacy of one month:47 people were followed up in one month after PTBD and PTBS. Total bilirubin, direct bilirubin and indirect bilirubin decreased about 25%. Total bilirubin decreased to normal in 9 patients, and the success rate of palliation was 19.1%.
(2) Preliminary analysis of the factors
The impact factors of one week palliative efficacy are postoperative one week infection (F= 3.215, P= 0.044), preoperative liver function (t=-1.994, P= 0.049). The impact factors of one month palliative efficacy are the methods of treatment (F=4.021, P=0.025), the time of bile duct obstruction (r=0.422, P=0.003), postoperative one month biliary tract infection (t=-2.269, P=0.028), degree of stenosis (t=3.665, P=0.001), preoperative liver function (t=-3.840, P＜0.001) and preoperative TB (r=0.363, P=0.012).
(3) Logistic regression analysis
Logistic regression analysis results of one week palliative efficacy:logistic regression model was significant(x2= 4.156, P= 0.041). Fitting equation was fine, Negelkerke R2 was 0.150. Parameter estimates was made:The patients with MOJ which complicated postoperative infection had a worse palliative efficacy (OR= 0.552,95% CI 0.315～0.968). The Palliative effective rate of non-hilar obstruction was 2.653 times as high as of hilar MOJ (OR= 2.653,95% CI 0.988～7.121). Postoperative jaundice reduced faster in the patients with the higher preoperative TB (OR= 1.004,95% CI,1.000～1.007).
The logistic regression analysis results of one month Palliative efficacy:logistic regression model was significant (x2= 10.217, P= 0.001). Fitting equation was well, Negelkerke R2 equated to 0.437. Parameter estimation was made:The palliative success rate in the patients with non-hilar obstruction was 13.706 times as high as in the patients with of hilar MOJ (OR= 13.706,95% CI was 2.087～90.030). Stent group (internal drainage) has the highest success rate, while the success rate of external drainage group was the lowest (OR= 4.574,95% CI 0.964～21.704).
Conclusions
(1) There is a wonderful short-term palliative efficacy for MOJ after PTBD and PTBS. Total bilirubin almost decreased 42% and 75% respectively in one week and one month after PTBD and PTBS. The palliative effective rate in one week after PTBD and PTBS is 71.2%, and the palliative success rate in one month is 19.1%.
(2)Postoperative biliary tract infection and sepsis, preoperative liver function C level are risk factors of one week palliative efficacy; These patients with non-hilar MOJ had a better palliative efficacy compared with the patients with hilar MOJ. Palliative efficacy of MOJ with higher postoperative TB shows better.
(3) The impact factors of one month palliative success rate after PTBD and PTBS would be obstructive position, the methods of treatment, preoperative liver function, degree of stenosis, preoperative TB, the time of bile duct obstruction and postoperative one month biliary tract infection. The total bilirubin in the patients with non-hilar MOJ Child-Pugh B degree, partial stenosis and treated by stenting are more likely to return to normal level. The total bilirubin in the patients with long-time obstruction, higher preoperative TB and biliary tract infection in one month are hard to return to normal level.
(4) Unilateral or bilateral drainage styles, complicated hemobilia after PTBD and PTBS have no significant effect for short-term palliative efficacy after statistical analysis. However, the choice of drainage styles didn't followed the randomized and controlled principle, and the cases of biliary hemorrhage are a few, so further studys are needed.
(5) These factors such as:postoperative IB/TB, Bismush type of hilar MOJ, the length of stenosis, degree of bile duct dilatation, the cause of MOJ, the gender and age of these patients with MOJ, have no significant effect for short-term palliative efficacy after PTBD and PTBS.
恶性梗阻性黄疸(Malignant Obstructive Jaundice, MOJ)是一组由胆管系统管腔内、外或管壁本身的恶性病变引起的胆管机械性阻塞,病原包括胆管癌、胆囊癌、原发性肝癌、壶腹癌、胰头癌及肝门区、胰腺区转移癌等,常造成阻塞远端的胆管扩张,可伴有胆道感染。胆管梗阻后引起毛细胆管扩张,伴随微绒毛消失和细胞间连接改变,使毛细胆管通透性增加,导致胆汁成分反流入血液和淋巴液。另外,胆管梗阻可引起肝细胞膜极性发生改变,很多酶和转运器从毛细胆管面转移至窦面和侧面,使得部分已进入肝细胞的胆汁成分重新分泌到血液。胆红素返流入血液,发生阻塞性黄疸、继而肝功能衰竭成为患者致死的主要原因。
一般来说,恶性梗阻性黄疸的外科手术治疗仍是目前最重要和根治的方法。手术的方法主要为切除病变、胆管改道引流。但恶性梗阻性黄疸被发现时已多属晚期,能行外科根治术者仅占7%,姑息性胆肠吻合术也仅适用于19%的病例。对于不能手术治疗的患者,黄疸可直接导致患者死亡,据统计平均生存期不足3个月。由于皮肤严重黄染、瘙痒、并发胆道感染、腹胀和消化不良综合征,其生活质量也随之下降。在这种情况下有效持续的胆道引流减黄是首要的治疗措施,可以延长患者生存期和提高生活质量,并为进一步的抗肿瘤治疗打下基础。其中,经皮经肝胆道外引流术、内外引流术和胆道支架置入术是恶性阻塞性黄疸简易有效的微创治疗技术。相比以往手术治疗,现在患者只需要适当的镇静即可进行手术,且术后只需要很短的住院时间。近年来,由于介入治疗方法和器材的不断进步,使其取代了部分外科手术疗法,或成为外科手术前、后的重要协助手段。介入治疗恶性梗阻性黄疸,为一种姑息性治疗手段,着重于胆道系统的再通,对于减轻梗阻所致的黄疸、提高患者晚期生存质量、延长生存时间等方面有着重要意义。
经过60年的发展,经皮经肝穿刺胆道引流术(Percutaneous Transhepatic Biliary Drainage, PTBD)和支架置入术(Percutaneous Transhepatic Biliary Stenting, PTBS)在技术、材料等方面日臻完善,以其降黄效果好、并发症较少、病人痛苦少,已成为姑息治疗恶性梗阻性黄疸的最主要治疗方式。
PTBD和PTBS治疗MOJ可达到很好的降黄效果。但在临床工作中发现,PTBD或PTBS术后尤其是术后短期内胆红素下降的程度常存在较大的差异,甚至存在降黄效果不明显的情况。因此,除了基本技术、材料原因外,应尚存在其他的影响因素。
根据临床经验、胆管疾病的发病特点以及相关文献,本研究通过对影像学、化验指标、疾病情况、治疗情况和并发症等一系列可能与降黄效果有关的因素进行了比较全面的分析,探讨影响降黄效果的主要因素。
目的
探讨PTBD和PTBS治疗恶性梗阻性黄疸1周和1个月总胆红素下降情况及影响降黄效果的相关因素分析。材料与方法
2005年5月～2009年6月恶性梗阻性黄疸患者111例,男71例,女40例。年龄20-82岁,平均61.6±13.6岁。导致梗阻性黄疸的肿瘤分别为胆管癌52例(46.8%)、胰腺癌22例(19.8%)、胆囊癌6例(5.4%)、肝癌8例(7.2%)、壶腹周围癌7例(6.3%)、胰头转移癌7例(6.3%)、肝门转移癌9例(8.1%)。所有病人术前行详细的临床评价,包括病史采集、体格检查、超声或CT、MRI例检查和肝功能、血常规等化验分析。所有患者术前总胆红素(Total Bilirubin，TB)均大于60umol/L。
所有患者行PTBD或PTBS,根据不同情况行外引流管、内外引流管和金属裸支架置入治疗。
记录性别、年龄、术前胆道扩张程度、梗阻部位、狭窄段长度、Bismush分型、单双侧引流方式、治疗方法、病因、黄疸时间、术前胆管炎、梗阻程度、术前TB、术前IB/TB、术前肝功能、术后1周并发感染、术后并发胆道出血、术后1月存在感染等18项可能与降黄效果相关的指标。
降黄疗效判断：以总胆红素(Total Bilirubin, TB)的下降程度进行疗效判断。(1)、1周降黄效果：以1周TB下降比例了解不同因素对降黄效果的影响。行Logistic回归分析时,设定二分类降黄效果为结局变量,参考田伏洲等的降黄标准,以术后1周内总胆红素相对术前下降≥30%,并且临床观察皮肤、巩膜黄染逐渐减轻者为效果显著。否则,为效果欠佳(包括无效的患者)。(2)、术后1个月降黄效果：以术后1月TB值了解不同因素对1月降黄效果的影响。行Logistic回归分析时,以术后1个月时总胆红素是否下降至正常水平设定二分类结局变量。
应用SPSS13.0统计软件对数据进行统计学处理。采用配对样本t检验和基本频数分析,了解术后1周降黄效果和术后1月降黄成功率。再用Logistic回归分析筛选与降黄效果有关的变量。
结果
所有患者成功进行PTBD或PTBS,根据不同情况行外引流管(16例,14.4%)、内外引流管(55例,49.6%)和金属裸支架(40例,36.0%)置入治疗。共置入外引流管27根、内外引流管74根、金属裸支架53支。3例(2.7%)术中或术后出现胆道出血,32例(28.8%)术后并发化脓性胆管炎,18例(16.2%)术后出现败血症。术后未出现急性胰腺炎、急性肾功能衰竭等急重并发症。
1、术后1周降黄效果：全组患者平均总胆红素由术前的278.21±153.67umol/L降至术后一周的156.80±114.7umol/L,降幅达121.41±107.70umol/L;直应胆红素由术前的201.91±111.62umol/L降至117.90±87.40umol/L,降幅为84.01±75.48umol/L;间应胆红素则从76.30±55.63umol/L降至术后的38.90±37.41umol/L,降幅为37.40±48.01umol/L。统计学处理显示显著性差异(P<0.001)。总胆红素下降(42.0±30.5)%,效果显著者79例(71.2%)。
术后1月降黄效果：47人在PTBD或PTBS术后1月进行随访复查,总胆红素、直应胆红素和间应胆红素均较术前有较大的降幅,下降75%左右,下降至较低的水平。47例患者中总胆红素降至正常的患者有9例(19.1%)。
2、各因素的初步分析
初步分析影响1周降黄效果的因素有：术后1周并发感染(F=3.215,P=0.044)和术前肝功能(t=-1.994,P=0.049)。影响术后1月降黄效果的因素有：治疗方法(F=4.021,P=0.025)、黄疸时间(r=0.422,P=0.003)、术后1月感染情况(t=-2.269,P=0.028)、梗阻程度(t=3.665,P=0.001)、术前肝功能(t=-3.840,P<0.001)和术前TB(r=0.363, P=0.012)。
3、Logistic回归分析
1周降黄效果logistic回归方程的统计结果分析：logistic回归模型有统计学意义(x2=4.156,P=0.041)。方程拟合度尚可,Negelkerke R2为0.150。参数估计结果为：术后D7并发感染的MOJ的1周降黄效果较未并发感染的效果差(OR=0.552,95%CI为0.315～0.968)；梗阻部位中非肝门区MOJ的降黄有效率较高,为肝门区MOJ的2.653倍(OR=2.653,95%CI为0.988～7.121)；术前TB越高,术后黄疸下降速度越快(OR=1.004,95%CI为1.000～1.007)。
1月降黄效果logistic回归方程的统计结果分析：logistic回归模型有统计学意义(x2=10.217,P=0.001)。方程拟合度尚可,Negelkerke R2为0.437。参数估计结果为：梗阻部位中非肝门区MOJ的1月降黄成功率较高,为肝门区MOJ的13.706倍(OR=13.706,95%CI为2.087～90.030)；治疗方法中支架置入术(内引流)的1月降黄成功率最高,外引流最低(OR=4.574,95%CI为0.964～21.704)。
结论
(1) PTBD和PTBS治疗MOJ降黄效果明确,总胆红素、直应胆红素和间应胆红素在术后1周即下降42%,术后1个月下降75%左右。PTBD和PTBS治疗MOJ降黄成功率高,术后1个月即有19.1%的MOJ患者总胆红素下降至正常水平。
(2)术后并发胆道感染和败血症、术前肝功能C级是术后1周影响降黄效果的危险因素；非肝门区MOJ的降黄效果较肝门区MOJ的降黄效果好,术前TB较高的MOJ1周降黄效果可能更好。
(3)影响PTBD和PTBS术后1个月降黄成功率的因素有狭窄部位、治疗方法、术前肝功能、是否完全梗阻、术前TB、黄疸时间和术后1月感染情况。非肝门区、术前肝功能Child-Pugh B级、不完全梗阻、支架置入术后的MOJ术后总胆红素恢复正常的可能性大。术前黄疸时间长、术前TB值较高、术后1月仍存在感染的黄疸患者可能恢复较慢。
(4)虽然本组统计学分析显示：单双侧引流方式、并发胆道出血对PTBD和PTBS术后降黄效果无影响。但由于选择单双侧引流方式是在非随机对照的原则下进行,并发胆道出血的病例数较少,需进一步研究。
(5)术前胆管炎、Bismuth分型、术前IB/TB、狭窄段长度、胆管扩张程度、病因、性别、年龄对PTBD和PTBS术后短期内降黄效果无明显影响。
Background
Malignant obstructive jaundice (MOJ) is a group of mechanical bile duct obstruction due to malignant disease of the bile duct lumen and wall or the outer of bile duct, including cholangiocarcinoma, gallbladder cancer, hepatocellular carcinoma, ampullary carcinoma, pancreatic cancer and metastatic cancer, and so on. These tumors are often accompanied by blocking the proximal bile duct resulting in biliary tract dilatation and infection. Along with the obstruction, the inside pressure of bile duct and endothelial cell permeability increase and bilirubin enter into the blood, which can cause obstructive jaundice, sepsis, biliary cirrhosis, liver failure and hepatorenal syndrome, etc.
In general, surgery is still the most important and radical approach to treat malignant obstructive jaundice. Surgical approaches mainly include removal of lesions and surgical bile duct drainage. But malignant obstructive jaundice is found mostly when the tumors are on the advanced stage. Only 7% patients can suffer radical surgery and only 19% can be done by palliative biliary-enteric anastomosis. The incidence rate of postoperative complications and postoperative mortality are higher. For those patients with unresectable disease, progressive jaundice constitutes an immediate limitation to their survival and causes significant loss to their quality of life secondary to pruritis, malaise and cholangitis with the patients'average survival time less than 3 months. Effective and lasting decompression of the biliary tree is a priority therapeutic method including biliary drainage and placement of biliary stent. These procedures could be finished by these minimally invasive techniques: percutaneous transhepatic biliary drainage/stenting (PTBD and PTBS) and endoscopic retrograde biliary drainage (ERBD). Compared to surgery, patient can often be treated under moderate sedation with a short hospital stay.
In the last sixty years, the procedure of PTBD and PTBS has been progressing in skills and materials, and now has been the most important palliative technique in the treatment of MOJ because of its higher successful rate and better therapeutic effect comparing with ERBD.
PTBD and PTBS can reach a better relieving effect for MOJ. But in clinical, we found sometimes that PTBD and PTBS did not work as we expected, and the degree of palliation differed largely in these patients. So we thought there could be other influential factors.
Depending on clinical experience, characteristic of bile duct diseases and selected literatures, this study will discuss the influence factors of palliative effect of PTBD and PTBS from aspects of characteristic of imaging and chemical analysis, diseased and therapeutic conditions, and complications.
Objective
The purpose of the present study is to evaluate short-term palliative effect of PTBD and PTBS in MOJ, and to describe the influence factors of this palliative therapy.
Materials and Methods
111 cases of MOJ (,range 20-82 years, mean age 61.6 years) between May 2005 and June 2009 underwent clinical assessment. They were diagnosed as cholangiocarcinoma (n=52 cases,46.8%), pancreatic carcinoma (n=22,19.8%), gallbladder carcinoma (n=6,5.4%), liver cancer (n=8,7.2%), periampulllary carcinoma (n=7,6.3%), metastatic carcinoma of head pancreas (n=7,6.3%), metastatic carcinoma of hepatic hilum (n= 9,8.1%). Clinical analysis had been done in all cases through history-taking, physical examination, blood chemical and ultrasound or CT or magnetic resonance imaging examination. Serum total bilirubin exceeded 60 umol/L in 111 patients.
PTBD and PTBS was carried out in all patients, including 8.5F multi-lateral holes drainage tubes (COOK, USA) or bare metal stent (8mm or 10 mm diameter) placement.
Eighteen influence factors were recorded, which may be related to the palliative efficacy of MOJ, including perioperatively total bilirubin, direct bilirubin (DB), indirect bilirubin (IB), serum albumin (ALB), prothrombin time (PT), the degree of bile duct dilatation, location and length of stricture involving Bismuth type for hepatic hilar lesions, unilateral or bilateral drainage, the duration of jaundice, ascites, preoperative and post-operative suppurative cholangiti, bile duct bleeding after procedure, and so on. It is regarded as effective treatment that the total bilirubin decreased more than 30% on the 7th day after operation, based on Tian fuzhou palliative efficacy criterion. Multifactors analysis was done to explain whether the related factors affected the short-term palliative efficacy or not for MOJ after PTBD and PTBS.
Results
All patients underwent PTBD OR PTBS successfully with the success rate 100%. Twenty seven external drainage tubes (n=16,14.4%),74 internal and external drainage tubes (n=55,49.6%) and 53 bare metal stents (n=40,36.0%) were placed in bile ducts totally. Intraoperative or postoperative hemobilia were found in 3 cases (2.7%). Suppurative cholangitis happened in 32 cases (28.8%) and sepsis in 18 cases (16.2%). Acute pancreatitis, acute renal failure and other critical complications were not found in these cases.
(1) Palliative efficacy of one week (paired sample t test):preoperative total bilirubins (TB) were 278.21±153.67 umol/L, and postoperative total bilirubins were reduced to 153.80±114.7umol/L. There is statistically significant difference (P≤0.001) between TB and D7TB. Total bilirubin decreased (42.0±30.5)%, and it was effective in reducing of jaundice in 79 cases (efficient rate 71.2%).
Palliative efficacy of one month:47 people were followed up in one month after PTBD and PTBS. Total bilirubin, direct bilirubin and indirect bilirubin decreased about 25%. Total bilirubin decreased to normal in 9 patients, and the success rate of palliation was 19.1%.
(2) Preliminary analysis of the factors
The impact factors of one week palliative efficacy are postoperative one week infection (F= 3.215, P= 0.044), preoperative liver function (t=-1.994, P= 0.049). The impact factors of one month palliative efficacy are the methods of treatment (F=4.021, P=0.025), the time of bile duct obstruction (r=0.422, P=0.003), postoperative one month biliary tract infection (t=-2.269, P=0.028), degree of stenosis (t=3.665, P=0.001), preoperative liver function (t=-3.840, P＜0.001) and preoperative TB (r=0.363, P=0.012).
(3) Logistic regression analysis
Logistic regression analysis results of one week palliative efficacy:logistic regression model was significant(x2= 4.156, P= 0.041). Fitting equation was fine, Negelkerke R2 was 0.150. Parameter estimates was made:The patients with MOJ which complicated postoperative infection had a worse palliative efficacy (OR= 0.552,95% CI 0.315～0.968). The Palliative effective rate of non-hilar obstruction was 2.653 times as high as of hilar MOJ (OR= 2.653,95% CI 0.988～7.121). Postoperative jaundice reduced faster in the patients with the higher preoperative TB (OR= 1.004,95% CI,1.000～1.007).
The logistic regression analysis results of one month Palliative efficacy:logistic regression model was significant (x2= 10.217, P= 0.001). Fitting equation was well, Negelkerke R2 equated to 0.437. Parameter estimation was made:The palliative success rate in the patients with non-hilar obstruction was 13.706 times as high as in the patients with of hilar MOJ (OR= 13.706,95% CI was 2.087～90.030). Stent group (internal drainage) has the highest success rate, while the success rate of external drainage group was the lowest (OR= 4.574,95% CI 0.964～21.704).
Conclusions
(1) There is a wonderful short-term palliative efficacy for MOJ after PTBD and PTBS. Total bilirubin almost decreased 42% and 75% respectively in one week and one month after PTBD and PTBS. The palliative effective rate in one week after PTBD and PTBS is 71.2%, and the palliative success rate in one month is 19.1%.
(2)Postoperative biliary tract infection and sepsis, preoperative liver function C level are risk factors of one week palliative efficacy; These patients with non-hilar MOJ had a better palliative efficacy compared with the patients with hilar MOJ. Palliative efficacy of MOJ with higher postoperative TB shows better.
(3) The impact factors of one month palliative success rate after PTBD and PTBS would be obstructive position, the methods of treatment, preoperative liver function, degree of stenosis, preoperative TB, the time of bile duct obstruction and postoperative one month biliary tract infection. The total bilirubin in the patients with non-hilar MOJ Child-Pugh B degree, partial stenosis and treated by stenting are more likely to return to normal level. The total bilirubin in the patients with long-time obstruction, higher preoperative TB and biliary tract infection in one month are hard to return to normal level.
(4) Unilateral or bilateral drainage styles, complicated hemobilia after PTBD and PTBS have no significant effect for short-term palliative efficacy after statistical analysis. However, the choice of drainage styles didn't followed the randomized and controlled principle, and the cases of biliary hemorrhage are a few, so further studys are needed.
(5) These factors such as:postoperative IB/TB, Bismush type of hilar MOJ, the length of stenosis, degree of bile duct dilatation, the cause of MOJ, the gender and age of these patients with MOJ, have no significant effect for short-term palliative efficacy after PTBD and PTBS.
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