Comparing two techniques for bile duct access during ERCP
Endoscopic Ultrasound-guided Rendezvous Technique Versus Early Precut Papillotomy for Difficult Bile Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Multicenter Randomized Controlled Trial
NA · Chinese University of Hong Kong · NCT06010576
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT06010576 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing ERCP and have experienced difficulties in bile duct cannulation.
Not a fit: Patients who have prior biliary sphincterotomy or significant comorbidities that contraindicate endoscopy may not benefit from this study.
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 performed: Other studies have shown promising results with advanced ERCP techniques, suggesting that this approach may lead to improved outcomes.
Eligibility criteria
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 this trial is running
Shatin, New Territories
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bile Duct Diseases, ERCP, EUS