内镜下乳头括约肌小切开联合球囊扩张术与单独内镜下乳头切开术治疗胆总管结石的随机对照研究

Comparison of limited endoscopic sphincterotomy with balloon dilation(ESBD) with only endoscopic sphincterotomy(EST) for removal of bile duct stones: A randomized controlled study

目的 ：观察内镜下十二指肠乳头括约肌小切开联合球囊扩张术（limited endoscopic sphincterotomy with balloon dilation,ESBD）与经典的乳头切开术（endoscopic sphincterotomy,EST）取胆总管结石的有效性及安全性,探讨ESBD术在胆总管结石治疗中的临床疗效。方法：300例胆总管结石患者随机分为ESBD组（n=150）和EST组（n=150）。ESBD组先行乳头1/3～1/2小切开,然后行球囊扩张至造影所示胆总管最大直径,扩张最大直径不超过15 mm。EST组行乳头全切开术,两组均按常规方法取石。比较两组结石取出率、操作时间、结石取出采用的方法、结石取出所需的次数、术后胰腺炎及其他并发症。结果：两组在结石取出率方面没有显著性差异,首次取石成功率EST组90.0%,ESBD组94.7%（P≥0.05）,二次取石成功率两组均达到100%。对结石≥15 mm者,首次完整取石EST组75.9%,ESBD组90.4%,对大结石的取出两组有显著性差异（P〈0.05）,且ESBD组取石时间较EST组短。取石方法 EST组较ESBD组更多使用到了碎石器（38.0%vs.23.3%,P〈0.05）,尤其在结石≥15 mm者,EST组较ESBD组更多使用到了碎石器（87.0%vs.57.7%,P〈0.05）。两组术中及术后并发症总发生率无显著性差异（P≥0.05）。结论：ESBD取石有与EST取石相近的成功率,术后并发症无明显升高,但对较大胆总管结石,ESBD组在首次完全取石率、取石时间及碎石网篮使用上更有优势。

Objective：To evaluate the clinical efficacy of limited endoscopic sphincterotomy with balloon dilation（ESBD） in the treatment of common bile duct stones by comparing the efficacy and safety of the two methods,ESBD and endoscopic sphincterotomy（EST）. Methods：Between 2013 and 2015,300 consecutive patients with common bile duct stones were randomly assigned to groups that underwent EST or ESBD. Patients in the ESBD group underwent limited sphincterotomy（1 / 3 up to half of the sphincter） followed by balloon dilation to the size of the common bile duct or 15 mm,and patients in the EST group underwent complete sphincterotomy alone. Stones were removed using standard techniques. The primary outcome was percentage of stones cleared,and secondary outcomes included procedural time,method of stone extraction,number of procedures required for stone clearance,morbidities and other complications. Results：There was no significant difference between groups in percentage of stones cleared（EST vs. ESBD：100% vs.100%）. Complete stone removal in the first session was accomplished at higher rates with ESBD than with EST, particularly for stones ≥15 mm（75.9% vs. 90.4%,P〈0.05）. And ESBD was faster compared to ESD for large stones. More patients in the EST group（38.0%） than the ESBD group（23.3%） required mechanical lithotripsy（P〈0.05）,particularly for stones ≥15 mm（87.0%vs. 57.7%,P〈0.05）. Morbidities developed in 5.3% of patients in the EST group and 4% of patients in the ESBD group（P ≥0.05）. Conclusion：ESBD and EST clear bile stones with equal efficacy. However,ESBD reduces the need for mechanical lithotripsy and is higher complete stone removal in the first session and faster compared to EST for large stones.