Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06010576

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

Led by Chinese University of Hong Kong · Updated on 2026-02-19

188

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

C

Chinese University of Hong Kong

Lead Sponsor

T

Tokyo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two advanced techniques to improve bile duct access during endoscopic retrograde cholangiopancreatography (ERCP) for patients with pancreatobiliary diseases. This study compares endoscopic ultrasound-guided rendezvous (EUS RV), a newer method, with early precut papillotomy, an established technique, to address the challenge of difficult bile duct cannulation which occurs in about 15% of cases. The goal is to determine which approach offers better success and fewer complications during ERCP procedures. One group of participants will receive the EUS-guided rendezvous technique, involving the use of an echoendoscope to locate the bile duct for guidewire insertion, followed by standard ERCP to complete access. The other group will undergo early precut papillotomy, where one of three standard needle knife or papillotome techniques is applied to gain bile duct entry. Both procedures are advanced endoscopic methods performed by experienced specialists, with the choice of specific approaches tailored to patient anatomy and institutional practice. During the study, participants will be monitored for technical success in accessing the bile duct during their first ERCP session. Researchers will also assess procedure-related serious adverse events up to 30 days after ERCP, the time taken to achieve biliary access, and the need for additional rescue procedures if access fails. The study involves detailed clinical evaluations and follow-up to compare the safety and effectiveness of these two key endoscopic biliary access techniques over the course of treatment and recovery.

CONDITIONS

Brief Title

Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation
  • Native major papilla
  • Difficult bile duct cannulation, defined by 1 of the following: unsuccessful bile duct cannulation within 10 attempts, or within 10 minutes, or 2 unintended pancreatic duct cannulations or contrast opacifications
  • Written informed consent available
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent
  • Contraindications for endoscopy due to other health problems
  • Prior biliary sphincterotomy
  • Surgically altered upper gastrointestinal anatomy or duodenal obstruction preventing standard ERCP
  • Uncorrectable blood clotting problems (INR > 1.5) or low platelets (< 50,000) not fixed by transfusion
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure session

Participants undergo either the EUS-guided rendezvous technique or early precut papillotomy to achieve biliary access during ERCP.

1 procedure visit (in-person)

Follow-up

Duration - 30 days

Participants are monitored for procedure-related serious adverse events and the need for additional biliary drainage procedures for up to 30 days after the ERCP procedure.

Follow-up visits or contacts within 30 days after procedure

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Actively Recruiting

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Research Team

F

Felix Sia

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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