Endoscopy Unit, Department of Surgery, Ospedale Niguarda Ca Granda, Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Endoscopy. 2019 Jun;51(6):548-559. doi: 10.1055/a-0818-3638. Epub 2019 Feb 6.
Endoscopic papillary balloon dilation (EPBD) was introduced to overcome the risk of adverse events associated with endoscopic sphincterotomy in the removal of common bile duct (CBD) stones. We performed a meta-analysis of randomized controlled trials (RCTs) comparing efficacy and safety of EPBD vs. endoscopic sphincterotomy, focusing on stone size, balloon diameter, and balloon dilation time.
A multiple database search was performed, including MEDLINE, EMBASE and Cochrane Library, from their inception date until October 2017. RCTs comparing the efficacy and safety of EPBD vs. endoscopic sphincterotomy in the removal of CBD stones were included. Cumulative meta-analyses over time, and subgroup analyses according to stone size, and balloon diameter and dilation time were carried out.
25 RCTs met the inclusion criteria. Despite the cumulative meta-analysis showing a trend over time in favor of endoscopic sphincterotomy in studies published up to 2004, the conventional meta-analysis revealed that EPBD was equally efficacious compared with endoscopic sphincterotomy in stone removal at first attempt (odds ratio [OR] 0.95, 95 % confidence interval [CI] 0.65 - 1.38). Endoscopic sphincterotomy was superior to EPBD in terms of overall stone clearance (OR 0.65, 95 %CI 0.43 - 0.99) in studies published since 2002, but no differences emerged in studies using large ( ≥ 10 mm) balloons (OR 1.37, 95 %CI 0.72 - 2.62). No statistically significant difference in pancreatitis occurrence emerged between EPBD and endoscopic sphincterotomy (OR 1.35, 95 %CI 0.90 - 2.03). Pancreatitis was more common with EPBD than with endoscopic sphincterotomy in studies using balloons < 10 mm (OR 1.78, 95 %CI 1.07 - 2.97), whereas no difference emerged in studies using large balloons (OR 0.84, 95 %CI 0.46 - 1.53). EPBD had lower rates of bleeding and cholecystitis.
Our latest data confirm that EPBD is currently inferior to endoscopic sphincterotomy in terms of overall stone clearance. However, EPBD using large balloons (≥ 10 mm) was as effective as endoscopic sphincterotomy, both in stone clearance and the need for endoscopic mechanical lithotripsy, without carrying an increased risk of pancreatitis.
内镜下乳头气囊扩张术（EPBD）的引入是为了克服内镜下括约肌切开术在取胆总管（CBD）结石时相关不良事件的风险。我们对比较 EPBD 与内镜下括约肌切开术疗效和安全性的随机对照试验（RCT）进行了荟萃分析，重点关注结石大小、球囊直径和球囊扩张时间。
对 MEDLINE、EMBASE 和 Cochrane Library 等多个数据库进行了检索，检索时间从数据库建立至 2017 年 10 月。纳入比较 EPBD 与内镜下括约肌切开术取 CBD 结石疗效和安全性的 RCT。进行了时间累积荟萃分析，并根据结石大小、球囊直径和扩张时间进行了亚组分析。
25 项 RCT 符合纳入标准。尽管累积荟萃分析显示，在截至 2004 年发表的研究中，内镜下括约肌切开术的趋势更为有利，但常规荟萃分析显示，EPBD 在首次取石时与内镜下括约肌切开术同样有效（比值比 [OR] 0.95，95%置信区间 [CI] 0.65-1.38）。在 2002 年以后发表的研究中，内镜下括约肌切开术在总体结石清除方面优于 EPBD（OR 0.65，95%CI 0.43-0.99），但在使用大球囊（≥10mm）的研究中没有差异（OR 1.37，95%CI 0.72-2.62）。EPBD 与内镜下括约肌切开术在胰腺炎发生方面无统计学差异（OR 1.35，95%CI 0.90-2.03）。在使用球囊＜10mm 的研究中，EPBD 引起胰腺炎的发生率高于内镜下括约肌切开术（OR 1.78，95%CI 1.07-2.97），而在使用大球囊的研究中无差异（OR 0.84，95%CI 0.46-1.53）。EPBD 发生出血和胆囊炎的比例较低。
我们的最新数据证实，EPBD 在总体结石清除方面目前逊于内镜下括约肌切开术。然而，使用大球囊（≥10mm）的 EPBD 在结石清除和需要内镜机械碎石方面与内镜下括约肌切开术同样有效，且胰腺炎风险无增加。
