Sadeghi Amir, Arabpour Erfan, Rastegar Reyhaneh, Hosseinzadeh Ehsan, Tape Parya Mozafari Komesh, Zali Mohammad Reza
Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Indian J Gastroenterol. 2025 May 31. doi: 10.1007/s12664-025-01774-8.
Difficult biliary cannulation with unintentional pancreatic duct cannulation is a challenging issue, even for experienced endoscopists. This prospective, randomized, single-center trial aims to evaluate the safety and efficacy of two advanced rescue cannulation methods in this context: transpancreatic biliary sphincterotomy and pancreatic guidewire-assisted fistulotomy.
Patients with intact papilla who were planned to undergo bile duct cannulation were screened and those who experienced difficult cannulation with at least two inadvertent pancreatic duct cannulations following unsuccessful double guidewire technique attempts were randomly assigned one of two rescue cannulation techniques: pancreatic guidewire-assisted fistulotomy and transpancreatic biliary sphincterotomy. The primary outcome was the cannulation success rate and the secondary outcome was the frequency of cannulation-related adverse events (trial registration number: IRCT20230314057717N1).
Total 730 patients were screened and 194 were recruited according to the study protocol (97 in each group). Successful biliary cannulation was achieved in 93.8% (n = 91) of the pancreatic guidewire-assisted fistulotomy group and 81.4% (n = 79) of the transpancreatic biliary sphincterotomy group (p-value = 0.01). Multivariate analysis revealed that the transpancreatic biliary sphincterotomy technique and a normal common bile duct diameter were independently associated with unsuccessful cannulation. No significant differences were observed regarding pancreatitis and other adverse events between the two groups (p = 0.31).
In difficult biliary cannulation accompanied by inadvertent pancreatic duct cannulation, following unsuccessful double guidewire technique, pancreatic guidewire-assisted fistulotomy is superior to transpancreatic biliary sphincterotomy for biliary cannulation, with similar rates of adverse events.
即使对于经验丰富的内镜医师而言，困难胆管插管合并意外胰管插管也是一个具有挑战性的问题。这项前瞻性、随机、单中心试验旨在评估在这种情况下两种先进的补救插管方法的安全性和有效性：经胰胆管括约肌切开术和胰管导丝辅助瘘管切开术。
对计划进行胆管插管且乳头完整的患者进行筛选，那些在双导丝技术尝试失败后经历困难插管且至少有两次意外胰管插管的患者被随机分配到两种补救插管技术之一：胰管导丝辅助瘘管切开术和经胰胆管括约肌切开术。主要结局是插管成功率，次要结局是插管相关不良事件的发生率（试验注册号：IRCT20230314057717N1）。
共筛选了730例患者，根据研究方案招募了194例（每组97例）。胰管导丝辅助瘘管切开术组93.8%（n = 91）的患者成功实现胆管插管，经胰胆管括约肌切开术组为81.4%（n = 79）（p值 = 0.01）。多因素分析显示，经胰胆管括约肌切开术技术和胆总管直径正常与插管失败独立相关。两组之间在胰腺炎和其他不良事件方面未观察到显著差异（p = 0.31）。
在困难胆管插管合并意外胰管插管且双导丝技术失败后，胰管导丝辅助瘘管切开术在胆管插管方面优于经胰胆管括约肌切开术，不良事件发生率相似。
