内镜下乳头球囊扩张术与乳头括约肌切开术治疗胆总管结石的安全性和疗效分析

Endoscopic papillary balloon dilatation vs. endoscopic sphincteropapillotomy for common bile duct stones： a meta analysis

目的利用荟萃分析方法，评价内镜下乳头球囊扩张术（EPBD）与乳头括约肌切开术（EST）治疗胆总管结石的安全性及疗效。方法选取发表于1990年1月至2012年7月对比分析EPBD与EST治疗胆总管结石的随机对照试验研究，并应用荟萃分析方法评价近期和远期并发症等相关结局指标。结果共有12篇前瞻性随机对照研究纳入分析，包括1865例患者，其中EPBD组925例，EST组940例。EPBD组与EST组相比，结石总清除率降低（OR=0．64，95％C1：0．42～0．96，P=0．03）、胰腺炎发生率升高（OR=2．67，95％CI：1．61-4．43，P=0．00）、出血发生率降低（OR=0．12，95％CI：0．04—0．34，P=0．00）、总的远期并发症发生率降低（OR=0．53，95％CI：0．36～0．77，P=0．00）、急性胆囊炎发生率降低（OR=0．39，95％CI：0．18～0．84，P=0．02）、超过1年随访时间的结石复发率降低（OR=0．48，95％CI：0．26—0．90，P：0．02），差异均有统计学意义。而两组在结石一次清除率、总的近期并发症发生率以及急性胆管炎等方面的差异均无统计学意义（P〉0．05）。结论EPBD与EST相比术后出血发生率降低，更适合有凝血机制障碍的胆总管结石患者。EPBD随访1年以上的远期结石复发率低，但是术后总结石清除率较低，胰腺炎发生率更高。

Objective To evaluate the safety and efficacy between endoscopic papillary balloon dilatation （EPBD） and endoscopic sphincteropapillotomy （EST） for common bile duct stones using metaanalysis method. Methods Randomizd controlled trials comparing EPBD with EST for common bile duct stones and published from January 1990 to July 2012 were recruited. This meta-analysis was conducted to estimate short-term and long-term complications. Fixed random effect model or random effect model was established to analyze the data. Results Twelve randomizd controlled trials were included in this analysis. These studies included 1865 patients, 925 of them were treated with EPBD and 940 were treated with EST. The analysis of basic characteristics of these included studies showed that ： compared to EST, patients in the EPBD group were younger （OR = - 1.16, 95% CI： - 1.49 to -0. 84, P =0. 00）, while in two groups, there were no significant difference （P 〉 0. 05） in gender proportion, average size of stones, number of gallstones, previous cholecystectomy, the number of merged duodenal diverticulum, common bile duct diameter, the total follow-up time. Also, compared to EST, the overall stone clearance in the EPBD group was lower （ OR =0. 64, 95% CI： 0. 42 to 0. 96, P =0. 03） , panereatitis incidence was higher （ OR =2. 67, 95% CI： 1.61 to 4. 43, P =0. 00） , incidence of bleeding （ OR =0. 12, 95% CI： 0. 04 to 0. 34, P =0. 00）, acute choleeystitis （ OR =0. 39, 95% CI： 0. 18 to 0. 84, P =0. 02）, total long-term complication rate（ OR = 0. 53, 95% CI： 0. 36 to 0. 77, P = 0. 01 ） , stone recurrence rate more than a year were lower （ OR = 0.48, 95% CI： 0. 26 to 0. 90, P =0. 02）. While in two groups, there were no significant difference （P 〉0. 05） in the stone removal on 1 ^st attempt, the total near-term complications and acute cholangitis. Conclusions On the basis of lower rates of bleeding, EPBD seems to be preferred strategy over EST for endoscopic remove of common bile duct stones in patients who have coagulopathy. Although stone recurrence rate more than a year of EPBD is lower, but the overall stone clearance rate is lower and the risk of pancreatitis is higher than that of EST.