Comparison of endoscopic ultrasound-guided choledochoduodenostomy and endoscopic retrograde cholangiopancreatography in first-line biliary drainage for malignant distal bile duct obstruction: A multicenter randomized controlled trial
Phase 3
Recruiting
- Conditions
- A malignant distal biliary obstruction that is unresectable or presents a very high surgical risk
- Registration Number
- JPRN-UMIN000041343
- Lead Sponsor
- Wakayama-Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
Not provided
Exclusion Criteria
1) Radiological evidence of gastric outlet obstruction on CT, 2) Hilar biliary obstruction, 3) Surgically altered anatomy 4) ECOG performance status of 4, 5) Poorly controlled ascites, 6) History of endoscopic sphincterotomy (EST), 7) Biliary stenting, 8) Serious complication involving another organ, 9) Uncorrectable coagulopathy and/or thrombocytopenia, 10) Any other condition or situation determined by a study investigator to represent a reason for ineligibility.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent patency rate at 180 days after treatment
- Secondary Outcome Measures
Name Time Method Procedure success rate, clinical improvement rate, incident rate, procedure time, success rate of re-intervention, rate of successful stenting without dilatation (EUS-BD group only), survival time, and percentage of post-drainage chemotherapy