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胰十二指肠切除术后胰肠吻合的导管对黏膜吻合术与套入式吻合术:我们是否需要更多试验?一项采用试验序贯分析的系统评价和Meta分析

Duct-to-mucosa versus dunking techniques of pancreaticojejunostomy after pancreaticoduodenectomy: Do we need more trials? A systematic review and meta-analysis with trial sequential analysis.

作者信息

Kilambi Ragini, Singh Anand Narayan

机构信息

Department of Hepatobiliary Surgery and Liver Transplant, Institute of Liver and Biliary Sciences, New Delhi, India.

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

出版信息

J Surg Oncol. 2018 Apr;117(5):928-939. doi: 10.1002/jso.24986. Epub 2018 Mar 25.

Abstract

BACKGROUND

Pancreaticojejunostomy (PJ is the most widely used reconstruction technique after pancreaticoduodenectomy. Despite several randomized trials, the ideal technique of pancreaticojejunostomy remains debatable. We planned a meta-analysis of randomized trials comparing the two most common techniques of PJ (duct-to-mucosa and dunking) to identify the best available evidence in the current literature.

METHODS

We searched the Pubmed/Medline, Web of science, Science citation index, Google scholar and Cochrane Central Register of Controlled Trials electronic databases till October 2017 for all English language randomized trials comparing the two approaches. Statistical analysis was performed using Review Manager (RevMan), Version 5.3. Copenhagen: The Nordic Cochrane Center, The Cochrane Collaboration, 2014 and results were expressed as odds ratio for dichotomous and mean difference for continuous variables. P-value ≤ 0.05 was considered significant. Trial sequential analysis was performed using TSA version 0.9.5.5 (Copenhagen: The Copenhagen Trial Unit, Center for Clinical Intervention Research, 2016).

RESULTS

A total of 8 trials were included, with a total of 1043 patients (DTM: 518; Dunking: 525). There was no significant difference between the two groups in terms of overall as well as clinically relevant POPF rate. Similarly, both groups were comparable for the secondary outcomes. Trial sequential analysis revealed that the required information size had been crossed without achieving a clinically significant difference for overall POPF; and though the required information size had not been achieved for CR-POPF, the current data has already crossed the futility line for CR-POPF with a 10% risk difference, 80% power and 5% α error.

CONCLUSION

This meta-analysis found no significant difference between the two techniques in terms of overall and CR-POPF rates. Further, the existing evidence is sufficient to conclude lack of difference and further trials are unlikely to result in any change in the outcome. (CRD42017074886).

摘要

背景

胰肠吻合术(PJ)是胰十二指肠切除术后应用最广泛的重建技术。尽管有多项随机试验,但胰肠吻合术的理想技术仍存在争议。我们计划对比较两种最常用的PJ技术(导管对黏膜吻合和套入式吻合)的随机试验进行荟萃分析,以确定当前文献中最佳的可用证据。

方法

我们检索了截至2017年10月的Pubmed/Medline、科学网、科学引文索引、谷歌学术和Cochrane对照试验中央注册库电子数据库,查找所有比较这两种方法的英文随机试验。使用Review Manager(RevMan)5.3版进行统计分析。哥本哈根:北欧Cochrane中心,Cochrane协作网,2014年,结果以二分类变量的比值比和连续变量的均值差表示。P值≤0.05被认为具有统计学意义。使用TSA 0.9.5.5版进行试验序贯分析(哥本哈根:哥本哈根试验单位,临床干预研究中心,2016年)。

结果

共纳入8项试验,总计1043例患者(导管对黏膜吻合:518例;套入式吻合:525例)。两组在总体及临床相关胰瘘发生率方面无显著差异。同样,两组在次要结局方面也具有可比性。试验序贯分析显示,总体胰瘘发生率未达到临床显著差异时所需的信息量已达到;虽然临床相关胰瘘发生率未达到所需信息量,但当前数据已越过临床相关胰瘘发生率的无效线,风险差为10%,检验效能为80%,α错误为5%。

结论

这项荟萃分析发现,两种技术在总体和临床相关胰瘘发生率方面无显著差异。此外,现有证据足以得出两者无差异的结论,进一步的试验不太可能导致结果发生任何改变。(CRD42017074886)

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