Digestive Endoscopy Unit, Pôle Digestif Paris Bercy, Clinique de Bercy, Charenton-le-Pont, France.
Digestive Endoscopy Unit, University Hospital, Nantes, France.
Endoscopy. 2017 Oct;49(10):968-976. doi: 10.1055/s-0043-114411. Epub 2017 Jul 28.
Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group ( < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).
内镜下括约肌切开术联合大球囊扩张（ES-LBD）已被报道为一种替代内镜下括约肌切开术取胆管结石的方法。本多中心研究比较了完全内镜下括约肌切开术联合与不联合大球囊扩张术取大胆管结石的效果。这是第一项评价这些方法治疗单纯大胆总管（CBD）结石患者的随机多中心研究。2010 年至 2015 年，将 150 例 1 个或多个胆管结石≥13mm 的患者随机分为两组：73 例未行球囊扩张（常规组），77 例行球囊扩张（ES-LBD 组）。如果结石过大无法通过乳头取出，则随后进行机械碎石。两组均行完全内镜下括约肌切开术。如果常规操作失败，患者可以转为 ES-LBD。两组患者的结石数量和大小无差异。常规组患者 CBD 结石清除率为 74.0%，ES-LBD 组为 96.1%（ <0.001）。常规组患者需要机械碎石的比例显著更高（35.6%比 3.9%； <0.001）。两组患者的发病率无差异（常规组 9.3%比 ES-LBD 组 8.1%； =0.82）。总体而言，两组的费用和手术时间无显著差异，但常规组中接受机械碎石的患者费用和手术时间显著更高。常规组有 19 例患者操作失败，其中 15 例患者接受了挽救性 ES-LBD 治疗，成功清除了所有结石。对于治疗大 CBD 结石，与传统治疗相比，内镜下括约肌切开术联合大球囊扩张术具有相似的安全性和更高的效率，应作为一线治疗方法，也可作为挽救性治疗。本研究在 ClinicalTrials.gov 注册（NCT02592811）。
