Martin D J, Vernon D R, Toouli J
Copenhagen Trial Unit, Dept 71 02, Cochrane Hepato-Biliary Group, Blegdamsvej 9, Copenhagen Ø, DK-2100, DENMARK.
Cochrane Database Syst Rev. 2006 Apr 19(2):CD003327. doi: 10.1002/14651858.CD003327.pub2.
10% to 18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Treatment options for these stones include pre- or post-operative endoscopic retrograde cholangiopancreatography (ERCP) or open or laparoscopic surgery.
To systematically review the management of CBD stones by four approaches: (1) ERCP versus open surgical bile duct clearance. (2) Pre-operative ERCP versus laparoscopic bile duct clearance. (3) Post-operative ERCP versus laparoscopic bile duct clearance. (4) ERCP versus laparoscopic bile duct clearance in patients with previous cholecystectomy.
We systematically searched key relevant electronic databases, bibliographies of relevant papers, and abstracts of relevant subspecialty meetings until November 2005.
The quality of included trials was assessed by adequacy of allocation sequence generation, allocation concealment, blinding, and follow-up.
Published and unpublished data relevant to 12 predefined outcome measures were used to conduct fixed- and random-effects models meta-analyses, with exploration of heterogeneity and use of sensitivity and subgroup analysis where required.
Thirteen trials randomised 1351 patients. Eight trials (n = 760) compared ERCP with open surgical clearance, three (n = 425) compared pre-operative ERCP with laparoscopic clearance, and two (n = 166) compared post-operative ERCP with laparoscopic clearance. There were no trials of ERCP versus laparoscopic clearance in patients without an intact gallbladder. Methodology was considered adequate in at least two of three assessable fields in ten trials. A significantly increased number of total procedures (including for complications) per patient was seen in the ERCP arms in all three comparisons with weighted mean differences of 0.62 (95% CI 0.15 to 1.09), 0.96 (95% CI 0.96 to 0.96), and 1.09 (95% CI 0.93 to 1.24), respectively. ERCP was less successful than open surgery in CBD stone clearance (Peto OR 2.89, 95% CI 1.81 to 4.61) with a tendency towards higher mortality (risk difference 1%, 95% CI -1% to 4%). Laparoscopic CBD stone clearance was as efficient as pre- (Peto OR 1.00, CI 0.53 to 1.80) and post-operative ERCP (OR 2.27, 95% CI 0.37 to 13.9) and with no significant difference in morbidity and mortality. Laparoscopic trials universally reported shorter hospital stays in surgical arms. Insufficient data were reported for cost analysis.
AUTHORS' CONCLUSIONS: In the era of open cholecystectomy, open bile duct surgery was superior to ERCP in achieving CBD stone clearance. In the laparoscopic era, data are close to excluding a significant difference between laparoscopic and ERCP clearance of CBD stones. The use of ERCP necessitates increased number of procedures per patient.
因胆结石接受胆囊切除术的患者中,10%至18%存在胆总管结石。这些结石的治疗选择包括术前或术后内镜逆行胰胆管造影(ERCP),或开放手术或腹腔镜手术。
通过四种方法系统评价胆总管结石的治疗:(1)ERCP与开放手术胆管清理术对比。(2)术前ERCP与腹腔镜胆管清理术对比。(3)术后ERCP与腹腔镜胆管清理术对比。(4)在既往有胆囊切除术的患者中,ERCP与腹腔镜胆管清理术对比。
我们系统检索了关键相关电子数据库、相关论文的参考文献以及相关亚专业会议的摘要,直至2005年11月。
纳入试验的质量通过分配序列产生的充分性、分配隐藏、盲法和随访进行评估。
使用与12项预定义结局指标相关的已发表和未发表数据进行固定效应和随机效应模型的荟萃分析,探索异质性,并在需要时进行敏感性和亚组分析。
13项试验将1351例患者随机分组。8项试验(n = 760)比较了ERCP与开放手术清理,3项试验(n = 425)比较了术前ERCP与腹腔镜清理,2项试验(n = 166)比较了术后ERCP与腹腔镜清理。没有关于无完整胆囊患者中ERCP与腹腔镜清理对比的试验。在10项试验的三个可评估领域中,至少有两个领域的方法学被认为是充分的。在所有三项对比中,ERCP组每名患者的总手术次数(包括并发症相关手术)显著增加,加权平均差分别为0.62(95%CI 0.15至1.09)、0.96(95%CI 0.96至0.96)和1.09(95%CI 0.93至1.24)。ERCP在胆总管结石清理方面不如开放手术成功(Peto比值比2.89,95%CI 1.81至4.61),且有死亡率升高的趋势(风险差1%,95%CI -1%至4%)。腹腔镜胆总管结石清理与术前(Peto比值比1.00,CI 0.53至1.80)和术后ERCP(比值比2.27,95%CI 0.37至13.9)效果相当,且在发病率和死亡率方面无显著差异。腹腔镜试验普遍报告手术组住院时间更短。报告的数据不足以进行成本分析。
在开放胆囊切除术时代,开放胆管手术在实现胆总管结石清理方面优于ERCP。在腹腔镜时代,数据几乎排除了腹腔镜与ERCP清理胆总管结石之间的显著差异。使用ERCP需要增加每名患者的手术次数。