Vettoretto Nereo, Arezzo Alberto, Famiglietti Federico, Cirocchi Roberto, Moja Lorenzo, Morino Mario
General Surgery Montichiari, ASST Spedali Civili Brescia, v.le Mazzini 4, Chiari (BS), Italy, 25032.
Cochrane Database Syst Rev. 2018 Apr 11;4(4):CD010507. doi: 10.1002/14651858.CD010507.pub2.
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation.
To compare the benefits and harms of endoscopic sphincterotomy and stone removal followed by laparoscopic cholecystectomy (the single-stage rendezvous technique) versus preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy (two stages) in people with gallbladder and common bile duct stones.
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded Web of Science, and two trials registers (February 2017).
We included randomised clinical trials that enrolled people with concomitant gallbladder and common bile duct stones, regardless of clinical status or diagnostic work-up, and compared laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy procedures in people undergoing laparoscopic cholecystectomy. We excluded other endoscopic or surgical methods of intraoperative clearance of the bile duct, e.g. non-aided intraoperative endoscopic retrograde cholangiopancreatography or laparoscopic choledocholithotomy (surgical incision of the common bile duct for removal of bile duct stones).
We used standard methodological procedures recommended by Cochrane.
We included five randomised clinical trials with 517 participants (257 underwent a laparoscopic-endoscopic rendezvous technique versus 260 underwent a sequential approach), which fulfilled our inclusion criteria and provided data for analysis. Trial participants were scheduled for laparoscopic cholecystectomy because of suspected cholecysto-choledocholithiasis. Male/female ratio was 0.7; age of men and women ranged from 21 years to 87 years. The run-in and follow-up periods of the trials ranged from 32 months to 84 months. Overall, the five trials were judged at high risk of bias. Athough all trials measured mortality, there was just one death reported in one trial, in the laparoscopic-endoscopic rendezvous group (low-quality evidence). The overall morbidity (surgical morbidity plus general morbidity) may be lower with laparoscopic rendezvous (RR 0.59, 95% CI 0.29 to 1.20; participants = 434, trials = 4; I² = 28%; low-quality evidence); the effect was a little more certain when a fixed-effect model was used (RR 0.56, 95% CI 0.32 to 0.99). There was insufficient evidence to determine the effects of the two approaches on the failure of primary clearance of the bile duct (RR 0.55, 95% CI 0.22 to 1.38; participants = 517; trials = 5; I² = 58%; very low-quality evidence). The effects of either approach on clinical post-operative pancreatitis were unclear (RR 0.29, 95% CI 0.07 to 1.12; participants = 517, trials = 5; I² = 24%; low-quality evidence). Hospital stay appeared to be lower in the laparoscopic-endoscopic rendezvous group by about three days (95% CI 3.51 to 2.50 days shorter; 515 participants in five trials; low-quality evidence). There was very low-quality evidence that suggested longer operative time with laparoscopic-endoscopic rendezvous (MD 34.07 minutes, 95% CI 11.41 to 56.74; participants = 313; trials = 3; I² = 93%). The Trial Sequential Analyses of operating time and the length of hospital stay indicated that all the trials crossed the conventional boundaries, suggesting that the sample sizes were adequate, with a low risk of random error.
AUTHORS' CONCLUSIONS: There was insufficient evidence to determine the effects of the laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy techniques in people undergoing laparoscopic cholecystectomy on mortality and morbidity. The laparoscopic-endoscopic rendezvous procedure may lead to longer operating times, but it may reduce the length of the hospital stay when compared with preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy. However, no firm conclusions could be drawn because the quality of evidence was low or very low. If confirmed by future trials, these data might re-design the scenario of treatment of this condition, albeit requiring greater organisational effort. Future trials should also address issues such as quality of life and cost analysis.
胆囊结石合并胆管结石的治疗存在争议。更常用的方法是两阶段手术，即先行内镜括约肌切开术并取出胆管结石，随后进行腹腔镜胆囊切除术。腹腔镜 - 内镜会师术在单阶段手术中结合了这两种技术。
比较内镜括约肌切开术及取石后行腹腔镜胆囊切除术（单阶段会师技术）与术前内镜括约肌切开术再行腹腔镜胆囊切除术（两阶段）对胆囊及胆总管结石患者的益处和危害。
我们检索了Cochrane肝胆组对照试验注册库、CENTRAL、MEDLINE Ovid、Embase Ovid、科学引文索引扩展版（Web of Science）以及两个试验注册库（2017年2月）。
我们纳入了随机临床试验，这些试验纳入了胆囊和胆总管结石并存的患者，无论其临床状态或诊断检查情况如何，且比较了接受腹腔镜胆囊切除术患者的腹腔镜 - 内镜会师术与术前内镜括约肌切开术。我们排除了胆管术中清除的其他内镜或手术方法，例如非辅助术中内镜逆行胰胆管造影术或腹腔镜胆总管切开取石术（通过手术切开胆总管以取出胆管结石）。
我们采用了Cochrane推荐的标准方法程序。
我们纳入了五项随机临床试验，共517名参与者（257例接受腹腔镜 - 内镜会师技术，260例接受序贯方法），这些试验符合我们的纳入标准并提供了分析数据。试验参与者因疑似胆囊 -胆总管结石而计划接受腹腔镜胆囊切除术。男女比例为0.7；男性和女性年龄范围为21岁至87岁。试验的导入期和随访期为32个月至84个月。总体而言，五项试验被判定存在高偏倚风险。尽管所有试验均测量了死亡率，但仅在一项试验中报告了1例死亡，发生在腹腔镜 - 内镜会师组（低质量证据）。腹腔镜会师术的总体发病率（手术发病率加一般发病率）可能较低（RR 0.59，95%CI 0.29至1.20；参与者 = 434，试验 = 4；I² = 28%；低质量证据）；使用固定效应模型时效果更确定一些（RR 0.56，95%CI 0.32至0.99）。没有足够的证据来确定两种方法对胆管初次清除失败的影响（RR 0.55，95%CI 0.22至1.38；参与者 = 517；试验 = 5；I² = 58%；极低质量证据）。两种方法对临床术后胰腺炎的影响尚不清楚（RR 0.29，95%CI 0.07至1.12；参与者 = 517，试验 = 5；I² = 24%；低质量证据）。腹腔镜 - 内镜会师组的住院时间似乎缩短约三天（95%CI缩短3.51至2.50天；五项试验中的515名参与者；低质量证据）。有极低质量证据表明腹腔镜 - 内镜会师术的手术时间更长（MD 34.07分钟，95%CI 11.41至56.74；参与者 = 313；试验 = 3；I² = 93%）。手术时间和住院时间的累积序贯分析表明，所有试验均越过了传统界限，表明样本量足够，随机误差风险低。
没有足够的证据来确定腹腔镜 - 内镜会师术与术前内镜括约肌切开术对接受腹腔镜胆囊切除术患者的死亡率和发病率的影响。腹腔镜 - 内镜会师术可能会导致更长的手术时间，但与术前内镜括约肌切开术再行腹腔镜胆囊切除术相比，它可能会缩短住院时间。然而，由于证据质量低或极低，无法得出确凿结论。如果未来试验证实，这些数据可能会重新设计这种疾病的治疗方案，尽管这需要更大的组织努力。未来试验还应解决生活质量和成本分析等问题。
