Efficacy and Safety of Precut Fistulotomy vs Conventional Cannulation Technique as a Primary Approach to Biliary Access According to the Endoscopist Experience Degree in ERCP

What this Trial Is About

This research aims to compare two techniques for accessing the main bile duct during Endoscopic Retrograde Cholangiopancreatography (ERCP), which is used to treat bile duct diseases like choledocholithiasis, malignant and benign biliary stenosis. The trial focuses on difficult biliary cannulation cases and evaluates whether fistulotomy precut or conventional guidewire cannulation is more effective, also considering the experience level of the endoscopist performing the procedure. Participants will be randomly assigned to one of two primary cannulation techniques: fistulotomy precut using a needle knife with specific settings, or conventional cannulation with a sphincterotome and guidewire under fluoroscopy. These procedures will be performed by either high-experience endoscopists (over 200 ERCPs) or low-experience endoscopists (under 200 ERCPs), creating four groups to compare outcomes. The study period spans from August 2019 to March 2020. During the study, participants will undergo ERCP with data collected on patient demographics, clinical and biochemical information, imaging studies, and detailed procedure characteristics such as number of cannulation attempts and time to access the bile duct. Researchers will measure the success rate of biliary cannulation within 5 minutes, document adverse events, and assess technical success. Statistical analyses will compare results across techniques and endoscopist experience levels to evaluate safety and efficacy.

Efficacy of Fistulotomy for Biliary Cannulation