贝叶斯网状Meta分析预测腹腔镜胆总管探查术后胆道内支架引流与单纯一期缝合的临床疗效

Efficacy prediction of biliary drainage stenting versus primary duct closure alone after laparoscopic common bile duct exploration: a Bayesian network Meta analysis

  • 摘要: 目的:贝叶斯网状Meta分析预测腹腔镜胆总管探查术(LCBDE)后胆道内支架引流(BDS)与单纯一期缝合的临床疗效。
    方法:以 (“Choledocholithiasis” OR “common bile duct stone” OR “CBDS” OR “extrahepatic bile duct stone”) AND (“laparoscopic common bile duct exploration” OR “LCBDE”) AND (“primary duct closure” or “PDC”) AND (“T-tube drainage” or “TTD” or “T-tube”) AND (“biliary drainage stenting or BDS) AND (“clinical trials”)、胆总管结石、腹腔镜胆总管探查、T管引流、一期缝合、胆道内支架引流为检索词,检索PubMed、MedLine、Embase、the Cochrane Library、Web of Science、CNKI、万方等数据库。检索时间为1990年1月1日至2020年1月31日。纳入评价LCBDE后胆总管缝合行BDS、单纯一期缝合和T管引流临床疗效的随机对照研究(RCT)。BDS组为LCBDE后行BDS,一期缝合组为LCBDE后行单纯一期缝合,T管引流组为LCBDE后行T管引流。结局指标:术后总体并发症发生率、术后胆汁漏发生率、术后残留结石发生率。在Rstudio环境下应用GeMTC软件进行Meta分析。在贝叶斯框架下采用随机效应模型执行。采用马尔科夫链蒙特卡罗法直接评估和间接预测。采用Brooks-Gelman-Rubin作图法、迹图法和密度图法对模型收敛性进行评价。因各干预措施间没有闭环,不需要评估研究的一致性。同时绘制各结局指标不同胆总管缝合方式的等级概率矩阵图。
    结果:(1)文献检索结果:最终纳入符合标准的相关文献12篇。12篇文献均为RCT,文献累积样本量为982例,其中BDS组190例,一期缝合组296例、T管引流组496例。(2)贝叶斯网状Meta分析结果:①BDS组和一期缝合组患者术后总体并发症发生率均低于T管引流组(优势比=0.21,0.48,95%可信区间为0.06~0.52,0.24~0.87,P<0.05);间接预测BDS组和一期缝合组患者术后总体并发症发生率比较,差异无统计学意义(优势比=0.43,95%可信区间为0.12~1.30,P>0.05)。②BDS组术后胆汁漏发生率低于T管引流组(优势比=0.18,95%可信区间为0.02~0.86,P<0.05),一期缝合组与T管引流组术后胆汁漏发生率比较,差异无统计学意义(优势比=0.70,95%可信区间为0.27~1.70,P>0.05);间接预测BDS组和一期缝合组患者术后胆汁漏发生率比较,差异无统计学意义(优势比=0.25,95%可信区间为0.03~1.60,P>0.05)。③BDS组和一期缝合组分别与T管引流组患者术后残留结石发生率比较,差异均无统计学意义(优势比=0.58,1.40,95%可信区间为0.13~2.40,0.41~5.50,P>0.05);间接预测BDS组和一期缝合组患者术后残留结石发生率比较,差异无统计学意义(优势比=0.39,95%可信区间为0.05~2.70,P>0.05)。(3)3组患者术后总体并发症发生率等级排名:BDS组、一期缝合组、T管引流组术后总体并发症发生率排名第1的概率分别为0.08%、0.98%、98.94%,排名第2的概率分别为6.57%、92.38%、1.05%,排名第3的概率分别为93.36%、6.64%、0.01%,3组患者术后总体并发症发生率排序:T管引流组>一期缝合组>BDS组。BDS组、一期缝合组、T管引流组术后胆汁漏发生率排名第1的概率分别为1.25%、18.93%、79.82%,排名第2的概率分别为6.11%、74.01%、19.88%,排名第3的概率分别为92.64%、7.06%、0.30%,3组患者术后胆汁漏发生率排序:T管引流组>一期缝合组>BDS组。BDS组、一期缝合组、T管引流组术后残留结石发生率排名第1的概率分别为10.89%、67.37%、21.74%,排名第2的概率分别为16.09%、21.09%、62.82%,排名第3的概率分别为73.02%、11.55%、15.44%,3组患者术后残留结石发生率排序:一期缝合组>T管引流组>BDS组。
    结论:具有适应证的胆总管结石患者,LCBDE后优先采用BDS,可降低胆总管缝合相关并发症。本研究在http://www.crd.york.ac.uk/ero/注册,注册号为CRD42019137344。

     

    Abstract: Objective:To predict the efficacy of biliary drainage stenting (BDS) versus primary duct closure (PDC) alone after laparoscopic common bile duct exploration (LCBDE)using Bayesian network Meta analysis.
    Methods:Databases including PubMed, MedLine, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang were searched for literatures from January.1st 1990 to January. 31st 2020 with the key words of (“Choledocholithiasis” OR “common bile duct stone” OR “CBDS” OR “extrahepatic bile duct stone”) AND (“laparoscopic common bile duct exploration” OR “LCBDE”) AND (“primary duct closure” or “PDC”) AND (“T-tube drainage” or “TTD” or “T-tube”) AND (“biliary drainage stenting or BDS”) AND (“clinical trials”), 胆总管结石, 腹腔镜胆总管探查, T管引流, 一期缝合, 胆道内支架引流. The randomized controlled trials (RCTs) about comparison of efficacy among BDS, PDC alone and T-tube drainage after LCBDE were received and included. BDS group included patients who underwent BDS after LCBDE, PDC group included patients who underwent PDC alone after LCBDE, and T-tube drainage group included patients who underwent T-tube drainage after LCBDE. The primary outcomes were the incidence of postoperative overall complications, bile leakage and residual stones. GeMTC software was used for Meta analysis in the Rstudio environment. This study was conducted using the random effects model in Bayesian network. The Markov Chain Monte Carlo was used for direct evaluation and indirect prediction. The Brooks-Gelman-Rubing graphing method, tracing method and density plotting were used to evaluate the model convergence. No closed loop formed between intervention measures, so there was no need to evaluate consistency. The matrix of rank probabilities in terms of the outcomes were also calculated.
    Results:(1) Document retrieval: a total of 12 available RCTs were enrolled. There were 982 patients, including 190 in the BDS group, 296 in the PDC group, and 496 in the T-tube drainage group. (2) Results of Bayesian network meta analysis. ① The BDS group and PDC group had lower overall complication rate than T-tube drainage group [odds ratio (OR)=0.21, 0.48, 95% confidence interval (CI): 0.06-0.52, 0.24-0.87, P<0.05]. There was no significant difference in the indirectly predicted overall complication rate between the BDS group and PDC group (OR=0.43, 95% CI: 0.12-1.30, P>0.05). ② The BDS group had lower incidence of postoperative bile leakage than T-tube drainage group (OR=0.18, 95%CI: 0.02-0.86, P<0.05). There was no significant difference in the incidence of postoperative bile leakage between the PDC group and T-tube drainage group (OR=0.70, 95%CI: 0.27-1.70, P>0.05). There was no significant difference in the indirectly predicted incidence of postoperative bile leakage between the BDS group and T-tube drainage group (OR=0.25, 95%CI: 0.03-1.60, P>0.05). ③ T-tube drainage group had no significant difference in the incidence of postoperative residual stones compared with the BDS group and PDC group (OR=0.58,1.40, 95%CI: 0.13-2.40, 0.41-5.50, P>0.05). There was no significant difference in the indirectly predicted incidence of postoperative residual stones between the BDS group and PDC group (OR=0.39, 95%CI: 0.05-2.70, P>0.05). (3) Ranking of the incidence of postoperative complication among the three groups: for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the first in the incidence of overall complication was 0.08%, 0.98%, 98.94%, the probability of ranking the second was 6.57%, 92.38%, 1.05%, and the probability of ranking the third was 93.36%, 6.64%, 0.01%, respectively, showing the ranking list as T-tube drainage group >PDC group >BDS group in the incidence of overall complication. The probability of ranking the first in the incidence of postoperative bile leakage was 1.25%, 18.93%, 79.82% for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the second was 6.11%, 74.01%, 19.88%, and the probability of ranking the third was 92.64%, 7.06%, 0.30%, respectively, showing the ranking list as T-tube drainage group >PDC group >BDS group in the incidence of postoperative bile leakage. The probability of ranking the first in the incidence of postoperative residual stones was 10.89%, 67.37%, 21.74% for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the second was 16.09%, 21.09%, 62.82%, and the probability of ranking the third was 73.02%, 11.55%, 15.44%, respectively, showing the ranking list as PDC group >T-tube drainage group >BDS group in the incidence of postoperative residual stones.
    Conclusions: For patients with appropriate choledocholithiasis, BDS would be recommended first after LCBDE, which can reduce duct closure related complications. This study was registered at http://www.crd.york.ac.uk/ero/, with the registration number of CRD42019137344.

     

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