Comparing two techniques for bile duct access during ERCP
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
Run by Chinese University of Hong Kong · NCT06010576 · Data updated 2026-11-12
This study is testing whether a new technique using endoscopic ultrasound is better than a standard method for helping patients with difficult bile duct access during a procedure called ERCP.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Status | Recruiting |
| Started | September 5, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT06010576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing ERCP and have experienced difficulties in bile duct cannulation.
✕Probably not a fit
Patients who have prior biliary sphincterotomy or significant comorbidities that contraindicate endoscopy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness of endoscopic ultrasound-guided rendezvous technique with precut papillotomy for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) who experience difficult bile duct cannulation. The study aims to determine which method provides better outcomes in terms of successful bile duct access and reduced complications. Patients eligible for the trial must be 18 years or older and have a native major papilla with specific criteria for difficult cannulation. The trial will assess the safety and efficacy of these two advanced techniques in a controlled setting.
Why it matters
Potential benefit: If successful, this study could improve the success rates of bile duct cannulation and reduce complications associated with ERCP procedures.
How similar studies have gone: Other studies have shown promising results with advanced ERCP techniques, suggesting that this approach may lead to improved outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong Recruiting
Study contacts
- Principal investigator: Raymond Tang, MD — Chinese University of Hong Kong
- Study coordinator: Felix Sia
- Email: felixsia@cuhk.edu.hk
- Phone: 26370428
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.