Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
Recruiting now · Not applicable
Conditions studied: Bile Duct Diseases
In brief
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.
Key facts
- Study ID
- NCT06010576
- Run by
- Chinese University of Hong Kong
- People needed
- 188
- Starts
- 2023-09-05
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Prince of Wales Hospital, The Chinese University of Hong Kong — Shatin, New Territories, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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