经胆囊管胆道引流在肝移植胆道重建中的临床应用价值Meta分析

Clinical value of transcystic biliary drainage in the biliary reconstruction of liver transplantation:a meta analysis

目的评价经胆囊管胆道引流(transcytic bile drainage,TBD)对肝移植术后胆道并发症的预防作用。方法计算机检索Pub Med、EMbase、sino Med、Web of Science、the Cochrane Central Register of Controlled Trials(CENTRAL)、万方数据库、中国知网以及维普数据库等。查找并筛选出所有比较经胆囊管胆道引流(transcytic bile drainage,TBD)与T管引流(T-tube,T-T)或non-TBD对肝移植术后胆道并发症影响的随机对照试验(randomized controlled trial,RCT),同时手动检测纳入文献的参考文献,检索时间均为建库至2017年2月28日。主要结局指标:胆道并发症总的发生率、胆道狭窄、胆漏以及拔管相关性胆漏。按纳入、排除标准由2位评价者独立进行RCT的筛选、资料提取和质量评价后,采用Rev Man(5.30版)软件进行Meta分析,并采用GRADE pro3.6软件进行证据质量评价。结果共纳入文献6篇,其中TBD与T管引流(T-T)对照研究3篇,TBD与胆管直接吻合(primary closure)对照研究文献1篇,TBD、T-T与直接吻合三者对照研究2篇。纳入病例542例,其中TBD组347例,T-T组102例,non-TBD组133例。Meta分析结果显示:与T-T组相比,TBD虽然不能降低胆道并发症总的发生率和总的胆漏发生率(7.3%vs10.8%,RR=1.27,95%CI=0.50~1.16,P=0.21;23.9%vs 30.4%,RR=1.03,95%CI=0.30~1.45,P=0.30),但是能显著降低肝移植术后胆道狭窄和拔管后胆漏的发生率(14.3%vs 30.2%,RR=3.37,95%CI=0.33~0.75,P=0.0008;1.7%vs 18.8%,RR=2.48,95%CI=0.05~0.70,P=0.01)。与胆管直接吻合相比,TBD能降低肝移植术后胆道并发症总的发生率以及胆道狭窄的发生率,但差异没有统计学意义(25.8%vs 39.2%,RR=0.29,95%CI=0.58~1.50,P=0.77;14.0%vs 19.2%,RR=0.61,95%CI=0.54~3.24,P=0.54),并且不会明显增加胆漏的发生率(17.4%vs 15.8%,RR=0.47,95%CI=0.47~1.59,P=0.64)。结论在肝移植术后胆道并发症的预防上,TBD与胆管直接吻合相当,优于T管引流。因此,TBD在肝移植胆管重建中是可行的,并且具有一定的临床价值。

objective To compare the biliary complications after biliary reconstruction with or without transcystic biliary drainage（TBD） in liver transplantation（LT）. Methods A meta-analysis was performed on eligible literature in Pub Med, EMbase, sino Med, web of Science, the Cochrane Central Register of Controlled Trials, Wanfang Datebase, CNKI, VIP Datebase, and other databases from their establishment to Feb. 28, 2017, to screen the clinical controlled trials about transcystic biliary drainage（TBD）, T-tube drainage（T-T） and primary closure in the biliary reconstruction of LT. The major endpoints were overall biliary complications, bile leaks, biliary stricture, and tube removal related bile leak. After study selection, data extraction and quality assessment were conducted by two independent reviewers. Meta-analysis was performed by using the Rev Man 5.3.0 software. Results A systematic review and meta-analysis of 6 case-control cohort studies（3 trials with TBD or T-T; 1 trial with C-tube or primary closure; 2 trials with TBD, T-T, and primary closure） was performed to compare the biliary complications after biliary tract reconstruction with or without TBD in LT. 542 patients were included in the meta-analysis consisting of 347 in the TBD group, 102 in the T-tube group, and 133 in the primary closure group. The data analysis showed that the biliary tract reconstruction with TBD was significantly superior to T-T according to the incidence of biliary stricture and bile leak after removal（14.3% vs 30.2%, RR=3.37, 95%CI=0.33-0.75, P=0.0008; 1.7% vs 18.8%, RR=2.48, 95%CI=0.05-0.70, P=0.01）; However, their overall biliary complications and bile leak were similar（7.3% vs 10.8%, RR=1.27, 95%CI=0.50-1.16, P=0.21; 23.9% vs 30.4%, RR=1.03, 95%CI=0.30-1.45, P=0.30）. Meanwhile, the biliary tract reconstruction with TBD showed better but statistically insignificant outcomes than that with primary closure according to the incidence of overall biliary complications and biliary stricture（25.8% vs 39.2%, RR=0.29, 95%CI=0.58-1.50, P=0.77; 14.0% vs 19.2%, RR=0.61, 95%CI=0.54-3.24, P=0.54）; In addition, they showed equivalent outcomes for bile leak（17.4% vs 15.8%, RR=0.47, 95%CI=0.47-1.59, P=0.64）. Conclusion TBD was equivalent to primary closure and superior to T-tube in the prevention of the biliary complication. Hence, the usage of TBD in biliary tract reconstruction is feasible and useful for LT surgery.