Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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