摘要
目的应用多中心前瞻性随机对照研究方法,对胰十二指肠切除术(Pancreaticoduodenectomy,PD)中残胰消化道的重建方式——捆绑式胰肠吻合术(Binding Pancreaticojejunostomy,BPJ)、捆绑式胰胃吻合术(Binding Pancreaticogastrostomy,BPG)进行对比研究,评价两者的临床疗效。
方法参与本项研究的专家小组包括浙江大学医学院附属邵逸夫医院的蔡秀军教授和洪德飞教授医疗小组、上海交通大学附属新华医院刘颖斌教授医疗小组、华中科技大学同济医学院附属同济医院秦仁义教授医疗小组、哈尔滨医科大学附属二院崔云甫教授医疗小组、浙江大学医学院附属第二医院李江涛教授医疗小组。对2009年11月至2012年1月的多中心的136例行PD患者采用前瞻性双盲随机对照试验研究方法,随机分成BPJ组和BPG两组。通过分析比较术后胰瘘、胃排空障碍、术后出血、胆漏、腹腔感染等严重并发症发生率、死亡率、再手术率以及术后肛门排气时间、进食时间、术后住院时间等康复指标,评价BPJ和BPG的临床疗效。
结果本组共136例,其中BPJ组53例,BPG组83例。两组之间患者性别及年龄,既往史(包括吸烟史、饮酒史、高血压、糖尿病、既往腹部手术史)症状(腹痛、黄疸)、术前相关指标(血清淀粉酶、空腹血糖)、术前住院时间,不存在统计学差异(P>0.05),两组具有可比性。胃十二指肠溃疡病史,两组存在统计学差异(p<0.05)。对比术中相关指标(手术时间、失血量、输血量、胰腺质地、胰腺游离长度、胰管断端直径等),不存在统计学差异(P>0.05)。BPJ组与BPG组术后肛门排气时间,拔除胃管时间,进食半流质时间,术后住院时间均无显著统计学差异(P>0.05)。BPJ组53例,术后并发胃排空障碍5例,切口感染3例,胰漏6例(胰漏发生率11.3%),胆漏2例,消化道出血1例,腹腔内脓肿1例,肺炎2例,心律失常1例；术后5d因腹腔内出血、多器官功能衰竭而死亡1例(死亡率为1.9%)；BPG组患者83例,术后并发胃排空障碍11例,切口感染1例,胰漏5例(胰漏发生率为6.0%。),胆管炎1例,胆漏5例,消化道溃疡1例,肠瘘1例,腹腔内脓肿2例,肺炎7例,心律失常1例,均保守治疗痊愈出院。BPG组术后并发上消化道出血3例(术后出血率3.6%),其中有2例术后2d上消化道出血,1例术后1w上消化道出血,再次进腹探查,均发现为胰腺残端出血,予以止血后痊愈出院。无围手术期死亡(死亡率为0%)。
结论BPG组胰瘘发生率低于BPJ组,BPG组胃排空障碍、胆漏并发症高于BPJ组,但均无统计学差异(P>0.05)；术后恢复指标比较也无统计学差异。与文献报告的传统胰肠吻合和胰胃吻合术比较,BPJ与BPG均是安全有效的胰消化道重建方式。
Objective Through the Pancreaticoduodenectomy(PD) with residual pancreatic and digestive tract reconstruction by the way of Binding Pancreaticojejunostomy(BPJ) or Binding Pancreaticogastrostomy(BPG) combined with multi-center prospective randomized controlled clinical trials, to discuss clinical effect by comparative study of BPJ and BPG.
Methods There'er total six professional study teams including Professor Xiu-Jun Cai team and Dei-Fei Hong team in SRRS Hospital Affiliated to Medical School of Zhejiang University、Professor Ying-Bin Liu team in Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine、Professor Ren-Yi Qin team in TongJi Hospital Affiliated to TongJi Medical College of Huazhong University of Science and Technology、Professor Yun-Fu Cui team in the Second Affiliated Hospital of Harbin Medical University and Professor Jiang-Tao Li in the Second Affiliated Hospital of Medical School of Zhejiang University. In this prospective double-blind randomized controlled clinical trials,136cases who underwent PD were recruited from general surgery department of multi-center between November2009and January2012.A11the patients are randomized divided into two treatment groups:BPJ group and BPG group. To evaluate the clinical effect of these two anastomosis by analyzing post-operation incidences of complication about pancreatic fistula、delayed gastric emptying、post-operative hemorrhage、bile leakage、intra-abdominal infection、 death、re-operation. Besides, post-operative recovery situation about anus exhaust time、 feeding time and post-operative hospitalization period stay were also evaluated.
Results There were total136cases,53cases were with BPJ,83cases were with BPG. The two treatment groups were comparable in multiple parameters, including demographics, medical history(smoking history、drinking history、hypertension、 diabetes、previous history of abdominal operation),symptom(abdominal pain、jaundice), pre-operative laboratory values(serum amylase、abdominal induced fluid), pre-operative hospitalization time; There is not existing significant difference (P>0.05). The two groups were comparable. But the history of gastric and duodenal ulcer is existing significant difference(P<0.05).Comparing BPJ with BPG in operative time、blood loss、 blood transfusions、pancreatic texture、pancreatic free length、pancreatic duct stump diameter, there were also not existing significant difference (P>0.05). Moreover, there were not existing significant difference in post-operative anus exhaust time, taking off gastric tube time, feeding time and post-operative hospitalization period stay etc.In BPJ group among53cases, there'er complications of5gastroparesis cases,3incision infection cases、6pancreatic fistula cases(The incidence of pancreatic fistula is11.3%)、2bile leakage cases、1peptic ulcer case、1intra abdominal abscess case、2pneumonia cases and1arrhythmia case. One died because of intra abdominal hemorrhage and MODS on post-operation day5(Death rate is1.9%).83cases were with BPG, among whom11had the complication of gastroparesis、1had incision infection、5had pancreatic fistula (The incidence of pancreatic fistula is11.3%)、1had cholangitis、5had bile leakage、1had peptic ulcer、1had intestinal fistula、1had intra abdominal abscess、7had pneumonia and1had arrhythmia, all of them were treated conservatively cured.3cases had complication of hemorrhage of upper digestive tractombining occurred on the post-operation day2、2、7respectively (The incidence is3.6%). All were founded pancreatic stump bleeding after exploration. No cases with the complication of death (Death rate is0%)
Conclusion The incidence of pancreatic fistula in BPG group is lower than BPJ group, the incidence of bile leakage and delayed gastric emptying in BPG is higher than BPJ. But there is not existing significant difference (P>0.05) between them. Post-operative recovery index is also not existing significant difference. Compared with traditional pancreaticogastrostomy and pancreaticojejunostomy reported, BPJ and BPG are both safe and effective ways as pancreatic and digestive tract reconstruction way in PD.
引文
[1]Shailesh VS, Sajid SQ, Nanda R, et al. Pancreatic Anastomoses after Pancreaticoduodenectomy:Do We Need Further Studies? World J Surg,2005,29: 1642-1649.
[2]DeOliveira ML, Winter JM, Schafer M, et al. Assessment of complications after pancreatic surgery:a novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann surg,2006,244(6):931-939.
[3]Reid-Lombardo KM, Famell MB, Crippa S, et al. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1507 patients:a report from the pancreatic anastomotic leak study group. J Gastrointest Surg,2007,11:1451-1458.
[4]Butturini G, Daskalaki D, Molinari E, et al. Pancreatic fistula:definition and current problems. J Hepatobiliary Pancreat Surg,2008,15(3):247-251.
[5]Shu You Peng, Jian Wei Wang, De Fei Hong, et.al. Binding pancreaticoenteric anastomosis:from binding pancreaticojejunostomy to binding pancreaticogastrostomy. Updates Surg,2011,63:69-74.
[6]彭淑牖,吴育连,彭承宏等.捆绑式胰肠吻合术(附28例报告)中华外科杂志1997,35(3)：158-159.
[7]Buc E, Flamein R, Golfier C, et al Peng's binding pancreaticojejunostomy after pancreaticoduodenectomy:a French prospective study. J Gastrointest Surg,2010, 14:705-710
[8]彭淑牖,洪德飞,刘颖斌,等.捆绑式胰胃吻合术.中华外科杂志2009,47(2)：139-142.
[9]彭淑牖,王许安,刘颖斌,等.彭氏胰胃吻合术Ⅰ型与Ⅱ型的比较(兼论Ⅲ型和Ⅳ型).外科理论与实践,2009,5：505-509.
[10]刘颖斌,许斌,王建伟等.彭氏Ⅱ型捆绑式胰肠吻合术,外科理论与实践,2003,8(5)：365-368.
[11]彭淑牖,刘颖斌,王家骅,等.保留幽门胰十二指肠切除术后胃排空障碍的预防 和治疗.中国实用外科杂志,1999,19(6)：344-345.
[12]Shyr YM, Su CH, et al. Dose drainage fluid amylase reflect pancreatic leakage after pancreaticoduodenectomy? World J Surg,2003,27(5):606-610.
[13]Pratt WB,Callery MP, Vollmer CM Jr, et al. Risk predicition for development of pancreatic fistula using the ISGPF classification scheme. World J Surg,2008,32: 419-428.
[14]彭淑牖,李江涛,曹利平,等。捆绑式胰管对黏膜吻合术.中华外科杂志2011.9835-838.
[15]Yeo CJ, Cameron JL, Lillemoe KD, et al. Does prophylacticoctreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Ann Surg 2000,232:419-429.
[16]Suc B, Msika S, Fingerhut A, Temporary fibrin glue occlusion of the main pancreatic duct in the prevention of intra-abdominal complications after pancreatic resection: prospective randomized trial. Ann Surg.2003 Jan;237(1):57-65.
[17]Marcus SG, Cohen H, Ranson JHC. Optimal management of the pancreatic remnant after pancreaticoduodenectomy. Ann Surg,1995,221:635-648.
[18]Baumel H, Huguier M, Manderscheid JC, et al. Results of resection for cancer of the exocrine pancreas:a study from the French Association of Surgery. Br J Surg.1994 Jan,81(1):102-107.
[19]Van Berge Henegouwen MI, De Wit LT, Van Gulik TM, et al. Incidence, risk factors, and treatment of pancreatic leakage after pancreaticoduodenectomy; drainage versus resection of the pancreatic remnant. J Am Coll Surg 1997,185:18-25。
[20]Bartoli FG, Arnone GB, Ravera G, et al. Pancreatic fistula and relative mortality in malignant disease after pancreaticoduodenectomy. Reviews and statistical meta-analysis regarding 15 years of literature. Anticancer Res 1991,11:1831-1848.
[21]梁力建,汤地,华鹏.胰十二指肠切除术210例临床分析.中华肝胆外科杂志,2004,10：1242-1244.
[22]邓贵龙,李海军,刘颖斌.胰十二指肠切除术的主要并发症及诊断与治疗,世界 华人消化杂.2003,11(5)：587-588。
[23]Kazanjian KK, Hines OJ, Eibl G, et al. Management of pancreatic fistulas afte pancreaticoduodenectomy:results in 437 consecutive. Arch Surg,2005,140: 849-856.
[24]赵平、朱预,曾宪九.胰瘘的引流.普外临床.1988；3：122-123。
[25]Warshaw, A. L., and Torchiana, D. L. Delayed gastric emptying afterpylorus-preserving pancreaticoduodenectomy. Surgery, gynecology obstetrics 1985.160:1-4.
[26]Yeo CJ,Cameron JL, Sohn JA.et al.650 consecutive pancerticoduodenectonies in the 1990s:pathology,complication and outcome.Ann Surg 1997,226:248-260。
[27]Kunstman JW, Fonseca AL, Ciarleglio MM.Comprehensive Analysis of Variables Affecting Delayed Gastric Emptying Following Pancreaticoduodenectomy. J Gastrointest Surg,2012,3:Epub ahead of print.
[28]Sugiyama M, Abe N, Ueki H, et。Z. A new reconstruction method for preventing delayed gastric emptying after pylorus-preserving pancreatoduodeneetomy[J]. Am J Surg,2004,187(6):743-746.
[29]Paraskevas KI, Avgerinos C, Manes C, et al. Delayed gastric emptying is associated wjth pylorus—presserving but not classical Whipple pancreaticoduodenectomy: review of the literature and critical reappraisal of the implicated pathomechanism[J]. World J Gastroenterol,2006,12(37):5951-5958.
[30]孙石.胰十二指肠切除术后并发功能性胃排空障碍的治疗.肝胆胰外科杂志,2002,12(2)：65-66.
[31]邵堂雷,杨卫平,彭承宏,等。139例胰十二指肠切除术后各种并发症的临床分析。中国普通外科杂志,2005,14(11)：850-852.
[32]Tran KT, Smeenk HC,Van Eijck CH, et al. pylorus—preserving pancreaticoduodenectomy versus standard Whipple procedurea prospective, randmoized, multicenter analysis of 170 patients with pancreatic and periampullary tumors [J]. Ann Sury.2004,240(5):738-745,
[33]徐泽宽,苗毅,蒋奎荣,再手术在胰十二指肠切除术后并发症处理中的疗效评价。中华肝胆外科杂志,2007,13(3)：171-173。
[34]Balachandran P, Sikora SS, Raghvendra RRV, et al. Haernorrhagic complication of pancreaticoduodenectomy. ANZ J Surg,2004,74:945-950.
[35]Yoon YS, Kim SW, Her KH, et aL Management of postoperative hemorrhage after pancreatoduodenectomy. Hepatogas troenterology,2003,50:2208-2212.
[36]徐军明,彭承宏,彭淑牖,298例胰十二指肠切除术后早期并发症分析。浙江大学学报(医学版),2002,31(6)：469-471.
[37]Mandai R, Eguchi Y, Tanaka M. Effects of profound hemodilution on small-intestinal wound healing in rabbits. J Surg Res.2001 Jul;99(1):107-13.
[38]王志军,吴阳,范正军。胰十二指肠切除术后胆瘘发生的危险因素。中华肝胆外科杂志,2007,13(6)：392-394.
[39]严律南,张延龄.胰十二指肠切除术后主要并发症的防治。中国现代手术学杂志,2002,6：172-173。
[40]Lillemoe KD, Cameron JL, Kim MP.et al, Does fibrin gluesealant decrease the rate of pancreatic fistula after pancreatieoduodcnectomy? resuhs of a prospective randomized trial. J Gastrointest Surg,2004,8:766-872.
[41]徐泽宽,郭峰,苗毅,等.502例胰十二指肠切除术后主要并发症的临床分析.中华肝胆外科杂志,2009.11,15(11)：809-812.
[42]程庆保,张柏和,张宝华.胰十二指肠切除术后早期并发症危险因素分析.中华普通外科杂志,2005,20(11)：684-685.
[43]Hughes C. Hurtuk MG, Ryehlik K, et al. Preoperative liver function tests and hemoglobin will predict complications following panereatieoduodeneetomy. J Gastrointest Surg,2008; 12(11)11822-1827.
[44]张波,曾庆东,李胜,等胰十二指肠切除术后腹腔感染发生的影响因素,中国普通外科杂志2004,13(2)：127-129。
[45]Oshiaki M, Kenichiro U, Yasuo H,et al. Long-Term Pancreatic Endocrine Function Following Pancreatoduodenectomy With Pancreaticogastrostomy. Journal of Surgical Oncology.2008,97:519-522.
[46]E.Lemaire, D.O'Toole, A.Sauvanet, et al.Functional and morphological changes in the pancreatic remnant following pancreaticodenectomy with pancreaticogas -tric anastomosis. British Journal of Surgery.2000,87:434-438.
[47]Flautner L, Tihanyi T, Szecseny A. Pancreatogastrostomy:an ideal complement to pancreatic head resection with preservation of the pylorus in the treatment of chronic pancreatitis. AmJ Surg,1985,150:608-611
[48]Cheng Q, Zhang B, Zhang Y. et al. Predictive factors complications after pancreaticoduodenectomy.J Surg Res.2007.139(1):22-29.
[49]张懿,张肇达,田伯乐,胰+二指肠切除术后早期并发症的危险因素。四川大学学报(医学版),2009；40(5)：960-961。
[50]谢学海,杨尹默,田孝东胰十二指肠切除术后围手术期。并发症的风险因素。中华肝胆外科杂志,2008,714(7)：455459.
[51]王建伟,许斌,蔡秀军,等.胰十二指肠切除术后胰漏的发生机制.世界华人消化杂志。2003；11：589-590.
[1]Shailesh VS, Sajid SQ, Nanda R, et al. Pancreatic Anastomoses after Pancreaticoduodenectomy:Do We Need Further Studies? World J Surg.2005;29: 1642-1649.
[2]DeOliveira ML. Winter JM, schafer M. et al. Assessment of complications after pancreatic surgery:a novel grading system applied to 633 patients undergoing pancreaticoduodenectomy [J]. Ann surg,2006,244(6):931-939.
[3]Reid-Lombardo KM, Famell MB, Crippa S et al. Pancreatic anastomotic leakage after pancreaticoduodenectomy in 1,507 patients:a report from the pancreatic anastomotic leak study group. J Gastrointest Surg,2007,11(11):1451-1458.
[4]Butturini G, Daskalaki D, Molinari E, et al. Pancreatic fistula:definition and current problems[J]. J Hepatobiliary Pancreat Surg,2008,15(3):247-251.
[5]田夫,向进见,李明忠,等.不同胰肠吻合方式的临床效果比较,世界华人消化杂志.2009.10.3160-3163.
[6]徐琳,吴志勇,等.捆绑式胰肠吻合与传统胰肠吻合术后并发症的比较.外科理论与实践2002 7(2)：155-157.
[7]Peng SY, Wang JW, Lau WY, et al. Conventional Verus Binding Pancreatiacojujunostomy After Pancreaticoduodenectomy. Ann Surg., 2007,245:692-698.
[8]Peng S, Mou Y, Cai X, et al. Binding pancreaticojejunostomy is a new technique to minimize leakage[J] Am J Surg,2002,183(3):283-285.
[9]Peng SY,Wang JW,Li JT,et al. Binding pancreaticojejunostomy-a safe and reliable anastomosis procedure.HPB 2004,6:154-160.
[10]Shu You Peng, Jian Wei Wang, De Fei Hong, et.al.Binding pancreaticoenteric anastomosis:from binding pancreaticojejunostomy to binding pancreaticogastrostomy Updates Surg (2011) 63:69-74.
[11]Buc E, Flamein R, Golfier C, et al Peng's binding pancreaticojejunostomy after pancreaticoduodenectomy:a French prospective study. J Gastrointest Surg,2010, 14:705-710.
[12]彭淑牖,吴育连,彭承宏等.捆绑式胰肠吻合术(附28例报告).中华外科杂志1997,35(3)：158-159.
[13]刘颖斌,许斌,王建伟,等.彭氏Ⅱ型捆绑式胰肠吻合术,外科理论与实践,2003,8：365-368.
[14]张秋学,杨冬山,张磊.捆绑式胰肠吻合103例疗效分。肝胆胰外科杂志,23(1)：68-69.
[15]刘颖斌,朱锦辉,王建伟,等.三种不同胰肠吻合术可靠性比较的实验研究.中华外科杂志,2006.3 44(5)：339-343.
[16]彭淑牖,洪德飞,刘颖斌,等.捆绑式胰胃吻合术.中华外科杂志,2009,47(2)：139-142.
[17]彭淑牖,洪德飞,刘颖斌,等.Ⅱ型捆绑式胰胃吻合术的临床疗效.中华外科杂志,2009,47(23)：1764-1766.
[18]王建伟,许斌,蔡秀军,‘等.胰十二指肠切除术后胰漏的发生机制.世界华人消化杂志,2003,11：589-590.
[19]彭淑牖,李江涛,曹利平,等.捆绑式胰管对黏膜吻合术.中华外科杂志,2011,9：834-838.
[20]黄从云,彭淑牖,朱剑华,等.捆绑式胰肠端侧吻合术.外科理论和实践,2011,16：452-454.
[21]洪德飞,彭淑牖,郑雪咏,等.完全腹腔镜胰十二指肠切除、胰空肠捆绑吻合术治疗十二指肠乳头癌一例.中华外科杂志,2006,3：357-358.
[22]洪德飞,成剑,刘小龙,等.捆绑式胰胃吻合术应用于腹腔镜胰腺中段切除术一例.中华普通外科,2012,27：344-345.