Health Technology Assessment Group, University of Aberdeen, Aberdeen, UK.
Br J Surg. 2012 Feb;99(2):160-7. doi: 10.1002/bjs.7809. Epub 2011 Dec 19.
Intraoperative cholangiography (IOC) is used to detect choledocholithiasis and identify or prevent bile duct injury. The aim of this study was systematically to review the randomized clinical trials of IOC for these two indications.
MEDLINE, Embase, the Cochrane Library, clinicaltrials.gov and the World Health Organization database of clinical trials were searched systematically (January 1980 to February 2011) to identify trials. Two authors performed the literature search and extracted data independently. Primary endpoints were bile duct injury and retained common bile duct (CBD) stones diagnosed at any stage after surgery. Preliminary meta-analysis was undertaken, but the trials were too methodologically heterogeneous and the outcome events too infrequent to allow meaningful meta-analysis.
Eight randomized trials were identified including 1715 patients. Six trials assessed the value of routine IOC in patients at low risk of choledocholithiasis. Two trials randomized all patients (including those at high risk) to routine or selective IOC. Two cases of major bile duct injury were reported, and 13 of retained CBD stones. No trial demonstrated a benefit in detecting CBD stones. IOC added a mean of 16 min to the total operating time.
There is no robust evidence to support or abandon the use of IOC to prevent retained CBD stones or bile duct injury. Level 1 evidence for IOC is of poor to moderate quality. None of the trials, alone or in combination, was sufficiently powered to demonstrate a benefit of IOC. Further small trials cannot be recommended.
术中胆管造影(IOC)用于检测胆总管结石并识别或预防胆管损伤。本研究旨在系统地回顾 IOC 用于这两种适应症的随机临床试验。
系统地检索了 MEDLINE、Embase、Cochrane 图书馆、clinicaltrials.gov 和世界卫生组织临床试验数据库(1980 年 1 月至 2011 年 2 月)以确定试验。两位作者独立进行文献检索和提取数据。主要终点是术后任何阶段诊断的胆管损伤和残留胆总管(CBD)结石。进行了初步的荟萃分析,但由于试验在方法学上存在很大的异质性,且结局事件过于罕见,无法进行有意义的荟萃分析。
确定了 8 项随机试验,包括 1715 例患者。6 项试验评估了在低胆总管结石风险患者中常规 IOC 的价值。2 项试验将所有患者(包括高风险患者)随机分为常规或选择性 IOC。报告了 2 例严重胆管损伤和 13 例残留 CBD 结石。没有试验显示在检测 CBD 结石方面有获益。IOC 平均增加了 16 分钟的总手术时间。
没有强有力的证据支持或放弃使用 IOC 来预防残留 CBD 结石或胆管损伤。IOC 的 1 级证据质量较差或中等。没有一项试验(单独或联合)有足够的效力证明 IOC 的益处。不能推荐进一步的小试验。