Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy (ERVPP)
Bile Duct Diseases
About this trial
This is an interventional treatment trial for Bile Duct Diseases focused on measuring ERCP, EUS
Eligibility Criteria
Inclusion Criteria: Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation Native major papilla Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast Written informed consent available Exclusion Criteria: Unable to provide written informed consent Contraindications for endoscopy due to comorbidities Prior biliary sphincterotomy Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a standard ERCP Uncorrectable coagulopathy (INR > 1.5) and thrombocytopenia (platelet < 50,000) by blood product transfusion Pregnant patients
Sites / Locations
- Prince of Wales Hospital, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EUS-guided rendezvous group (EUS RV group)
Early precut papillotomy group (EPP group)
In the EUS RV group, a linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.
In the EPP group, the precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome