Status:
RECRUITING
Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Tokyo University
Gifu University Graduate School of Medicine
Conditions:
Bile Duct Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Endoscopic retrograde cholangiopancreatography (ERCP) is the preferred therapeutic modality over surgery or interventional radiology procedures in many common benign or malignant pancreatobiliary dise...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06010576
Start Date
September 5 2023
End Date
June 30 2027
Last Update
December 9 2024
Active Locations (1)
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1
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong