Comparing Endoscopic Ultrasound-guided Rendezvous and Early Precut Papillotomy for Difficult Bile Duct Cannulation During ERCP in a Multicenter Randomized Study

What this Trial Is About

Researchers are comparing two advanced techniques for gaining biliary access during endoscopic retrograde cholangiopancreatography ERCP in patients with difficult bile duct cannulation. ERCP is commonly used to treat benign and malignant pancreatobiliary diseases, but biliary access fails in up to 15% of cases. The study focuses on evaluating the clinical effectiveness of Endoscopic Ultrasound-guided Rendezvous EUS RV versus early precut papillotomy, both advanced methods recommended for rescue biliary access after failed standard cannulation attempts. Participants are randomly assigned to receive either the EUS-guided rendezvous procedure or early precut papillotomy. The EUS RV involves using an echoendoscope and fine needle to access the bile duct, advance a guidewire through the biliary tree, and complete cannulation via ERCP. The precut papillotomy group uses one of three accepted needle knife or papillotome techniques to facilitate biliary access after failed standard cannulation. Both methods are applied during the ERCP procedure by experienced investigators. During the study, participants undergo ERCP with the assigned technique to attempt biliary access. Researchers will measure technical success during the first ERCP session, procedure time, and any serious procedure-related adverse events within 30 days. The need for additional rescue biliary drainage procedures after failed access will also be recorded. This trial is conducted across multiple centers and includes follow-up assessments to monitor outcomes and safety through 30 days post-procedure.

Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy