NCT06010576 Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
| NCT ID | NCT06010576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Bile Duct Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2023-09-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Raymond Tang, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06010576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bile Duct Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06010576 currently recruiting?
Yes, NCT06010576 is actively recruiting participants. Contact the research team at felixsia@cuhk.edu.hk for enrollment information.
Where is the NCT06010576 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06010576 clinical trial?
NCT06010576 is sponsored by Chinese University of Hong Kong. The principal investigator is Raymond Tang, MD at Chinese University of Hong Kong. The trial plans to enroll 188 participants.