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RECRUITING
NCT06010576
NA

Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

Selective bile duct cannulation is the most important step in endoscopic retrograde cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP cannulation technique recommended by guidelines for rescue of difficult biliary access, but it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel interventional EUS technique that has been increasingly performed after failed biliary access by advanced ERCP cannulation techniques.

Official title: Endoscopic Ultrasound-guided Rendezvous Technique Versus Early Precut Papillotomy for Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2023-09-05

Completion Date

2027-06-30

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

PROCEDURE

EUS-guided rendezvous

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.

PROCEDURE

Early precut papillotomy 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

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong