National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
Department of Radiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
J Gastroenterol Hepatol. 2020 Dec;35(12):2176-2183. doi: 10.1111/jgh.15120. Epub 2020 Jun 23.
Double-guidewire technique (DWT) has been successfully performed by experts in difficult biliary cannulation as an advanced technique. This study aimed to define the learning curve and safety of DWT by trainees during hands-on endoscopic retrograde cholangiopancreatography (ERCP) training.
Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct was inadvertently cannulated. DWT was performed by two trainees randomly under trainers' guidance. The primary outcome was the success rate of DWT biliary cannulation of trainees. Cumulative sum analysis was used to generate visual learning curves.
A total of 60 patients with difficult cannulation were enrolled. The main indications for ERCP were common bile duct stones (65%) and biliary stricture (31.7%). The learning curve analysis showed that to achieve a 70% rate of successful DWT, 12 procedures were needed for trainee A and 15 for trainee B. Higher targeted success rate of DWT could be achieved if the number of DWT procedures increased. Compared with the early stage of learning DWT (case 1 to 15 for each trainee), trainees had significantly higher DWT success rate in the late stage (36.7% [11/30] vs 80% [24/30], P = 0.001). The final success rate of cannulation was 98.3% (59/60). The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60), respectively.
Double-guidewire technique was safely performed by two novel trainees during hands-on ERCP training. Fifteen procedures may be enough for trainees to achieve the competency of performing DWT. (Clinicaltrials.gov number: NCT03707613).
双导丝技术（DWT）已被专家成功应用于困难的胆管插管，作为一种先进技术。本研究旨在通过内镜逆行胰胆管造影（ERCP）培训期间的学员来确定 DWT 的学习曲线和安全性。
如果胆管插管困难且胰管无意中被插管，则符合本研究纳入标准的患者可接受研究。两名学员在培训师的指导下随机进行 DWT。主要结果是学员 DWT 胆管插管的成功率。累积和分析用于生成直观的学习曲线。
共纳入 60 例困难插管患者。ERCP 的主要适应证是胆总管结石（65%）和胆管狭窄（31.7%）。学习曲线分析表明，学员 A 需 12 例，学员 B 需 15 例即可达到 70%的 DWT 成功率。如果增加 DWT 例数，则可以实现更高的 DWT 靶向成功率。与学习 DWT 的早期阶段（每位学员第 1 例至第 15 例）相比，学员在晚期的 DWT 成功率明显更高（36.7%[11/30]比 80%[24/30]，P=0.001）。最终插管成功率为 98.3%（59/60）。总的 ERCP 后胰腺炎和不良事件发生率分别为 6.7%（4/60）和 8.3%（5/60）。
两名新手学员在实际的 ERCP 培训期间安全地进行了 DWT。对于学员来说，15 例操作可能足以使其达到执行 DWT 的能力。（临床试验注册号：NCT03707613）。
