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一期腹腔镜胆总管探查取石术与二期内镜下取石后腹腔镜胆囊切除术治疗胆囊结石合并胆总管结石的疗效比较:随机试验的系统评价和荟萃分析,并采用试验序贯分析。

Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with gallbladder stones with common bile duct stones: systematic review and meta-analysis of randomized trials with trial sequential analysis.

机构信息

Department of Gastrointestinal Surgery and Liver Transplantation, All India Institute of Medical Sciences, New Delhi, India.

Department of HPB Surgery, Institute of Liver and Biliary Sciences, Room No. 3026, 3rd floor, Phase I, ILBS, New Delhi, India.

出版信息

Surg Endosc. 2018 Sep;32(9):3763-3776. doi: 10.1007/s00464-018-6170-8. Epub 2018 Mar 30.


DOI:10.1007/s00464-018-6170-8
PMID:29603004
Abstract

BACKGROUND: The ideal management of common bile duct (CBD) stones associated with gall stones is a matter of debate. We planned a meta-analysis of randomized trials comparing single-stage laparoscopic CBD exploration and cholecystectomy (LCBDE) with two-stage preoperative endoscopic stone extraction followed by cholecystectomy (ERCP + LC). METHODS: We searched the Pubmed/Medline, Web of science, Science citation index, Google scholar and Cochrane Central Register of Controlled trials electronic databases till June 2017 for all English language randomized trials comparing the two approaches. Statistical analysis was performed using Review Manager (RevMan) [Computer program], Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014 and results were expressed as odds ratio for dichotomous variables and mean difference for continuous. p value ≤ 0.05 was considered significant. Trial sequential analysis (TSA) was performed using TSA version 0.9.5.5 (Copenhagen: The Copenhagen Trial Unit, Centre for Clinical Intervention Research, 2016). PROSPERO trial registration number is CRD42017074673. RESULTS: A total of 11 trials were included in the analysis, with a total of 1513 patients (751-LCBDE; 762-ERCP + LC). LCBDE was found to have significantly lower rates of technical failure [OR 0.59, 95% CI (0.38, 0.93), p = 0.02] and shorter hospital stay [MD - 1.63, 95% CI (- 3.23, - 0.03), p = 0.05]. There was no significant difference in mortality [OR 0.37, 95% CI (0.09, 1.51), p = 0.17], morbidity [OR 0.97, 95% CI (0.70, 1.33), p = 0.84], cost [MD - 379.13, 95% CI (- 784.80, 111.2), p = 0.13] or recurrent/retained stones [OR 1.01, 95% CI (0.38, 2.73), p = 0.98]. TSA showed that although the Z-curve crossed the boundaries of conventional significance, the estimated information size is yet to be achieved. CONCLUSIONS: Single-stage LCBDE is superior to ERCP + LC in terms of technical success and shorter hospital stay in good-risk patients with gallstones and CBD stones, where expertise, operative time and instruments are available.

摘要

背景:胆石症相关胆总管结石的理想治疗方法仍存在争议。我们计划对比较一期腹腔镜胆总管探查取石术(LCBDE)与术前两期内镜下取石术(ERCP+LC)的随机试验进行荟萃分析。

方法:我们检索了 Pubmed/Medline、Web of science、Science citation index、Google scholar 和 Cochrane Central Register of Controlled trials 电子数据库,截至 2017 年 6 月,检索所有比较两种方法的英文随机试验。使用 Review Manager(RevMan)[计算机程序](Version 5.3. Copenhagen:The Nordic Cochrane Centre,The Cochrane Collaboration,2014)进行统计分析,结果表示为二分类变量的优势比和连续变量的均数差。p 值≤0.05 认为有统计学意义。采用 TSA 版本 0.9.5.5(Copenhagen:The Copenhagen Trial Unit,Centre for Clinical Intervention Research,2016)进行试验序贯分析(TSA)。PROSPERO 试验注册号为 CRD42017074673。

结果:共纳入 11 项研究,共 1513 例患者(LCBDE 组 751 例,ERCP+LC 组 762 例)。LCBDE 组的技术失败率显著降低[比值比(OR)0.59,95%可信区间(CI)(0.38,0.93),p=0.02],住院时间更短[MD -1.63,95% CI(-3.23,-0.03),p=0.05]。死亡率[OR 0.37,95% CI(0.09,1.51),p=0.17]、发病率[OR 0.97,95% CI(0.70,1.33),p=0.84]、费用[MD -379.13,95% CI(-784.80,111.2),p=0.13]或复发/残留结石[OR 1.01,95% CI(0.38,2.73),p=0.98]差异均无统计学意义。TSA 显示,尽管 Z 曲线穿过了常规显著性的边界,但估计的信息量尚未达到。

结论:在有经验、手术时间和器械的情况下,对于具有胆囊结石和胆总管结石的低危患者,一期 LCBDE 在技术成功率和住院时间方面优于 ERCP+LC。

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