Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India (A.C., J.Samanta, G.M., J.D., A.K., J.Shah, R.K.).
Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy (M.S., A.Fugazza, C.H., A.R.).
Ann Intern Med. 2024 Oct;177(10):1361-1369. doi: 10.7326/M24-0092. Epub 2024 Aug 27.
The standard salvage technique used for difficult bile duct cannulation is precut sphincterotomy, whereas endoscopic ultrasound-guided rendezvous technique (EUS-RV) is a relatively newer method. Prospective comparative data between these 2 techniques as salvage for biliary access in patients with benign biliary disease and difficult bile duct cannulation is lacking.
To compare EUS-RV and precut sphincterotomy as salvage technique for difficult bile duct cannulation in benign biliary obstruction.
Participant-masked, parallel-group, superiority, randomized controlled trial. (Clinical Trials Registry of India: CTRI/2020/07/026613).
Tertiary care academic institute from July 2020 to May 2021.
All patients with benign biliary disease and difficult bile duct cannulation requiring salvage strategy.
Patients were randomly assigned by computer-generated randomized blocks sequence in 1:1 fashion to either EUS-RV or precut sphincterotomy. Patients with failure in EUS-RV were crossed over to precut sphincterotomy and vice versa.
The primary outcome measure was technical success. The other outcome measures included procedure time, radiation dose, and adverse events.
In total, 100 patients were randomly assigned to EUS-RV ( = 50) and precut sphincterotomy ( = 50). The technical success rate (92% vs. 90%; = 1.00; relative risk, 1.02 [95% CI, 0.90 to 1.16]), median procedure time (10.1 vs. 9.75 minutes), and overall complication rate (12% vs. 10%; relative risk, 1.20 [CI, 0.39 to 3.68]) were similar between the 2 groups. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. All failed cases in either salvage group could be successfully cannulated when crossed over to the other group.
Single center study done by experts.
Endoscopic ultrasound-guided rendezvous technique and precut sphincterotomy have similar success rates as salvage techniques in the technically challenging cohort of difficult bile duct cannulation for benign biliary disease, with acceptable complications rates.
None.
在困难的胆管插管中，标准的挽救技术是预切开括约肌切开术，而内镜超声引导会师技术（EUS-RV）是一种相对较新的方法。在良性胆道疾病和困难胆管插管的患者中，这两种技术作为胆道进入的挽救方法的前瞻性对比数据尚缺乏。
比较 EUS-RV 和预切开括约肌切开术作为良性胆道梗阻中困难胆管插管的挽救技术。
参与者设盲、平行组、优效性、随机对照试验。（印度临床试验注册处：CTRI/2020/07/026613）。
2020 年 7 月至 2021 年 5 月的三级护理学术机构。
所有因良性胆道疾病和需要挽救策略而导致困难胆管插管的患者。
患者通过计算机生成的随机块序列以 1:1 的比例随机分配至 EUS-RV 或预切开括约肌切开术。EUS-RV 失败的患者交叉到预切开括约肌切开术，反之亦然。
主要结局指标是技术成功率。其他结局指标包括手术时间、辐射剂量和不良事件。
总共 100 例患者被随机分配至 EUS-RV（n=50）和预切开括约肌切开术（n=50）。技术成功率（92% vs. 90%；=1.00；相对风险，1.02[95%CI，0.90 至 1.16]）、中位手术时间（10.1 分钟 vs. 9.75 分钟）和总体并发症发生率（12% vs. 10%；相对风险，1.20[CI，0.39 至 3.68]）在两组之间相似。EUS-RV 组中有 5 例（10%）和预切开括约肌切开术组中有 5 例（10%）患者发生内镜逆行胰胆管造影术后胰腺炎。任何挽救组中失败的病例都可以在交叉到另一组后成功插管。
由专家进行的单中心研究。
在良性胆道疾病困难胆管插管的技术挑战性队列中，EUS-RV 和预切开括约肌切开术作为挽救技术具有相似的成功率，且并发症发生率可接受。
无。
