Efficacy and safety of Endoscopic Retrograde Stent Placement via Supra-papillar versus Trans-papillar Method for Malignant Biliary Obstruction: A Multicenter Prospective Randomized Study
- Conditions
- Neoplasms
- Registration Number
- KCT0005572
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
1. 18 years old or older
2. Patients with bile duct obstruction confined to the common bile duct in abdominal computed tomography or abdominal magnetic resonance imaging
3. If the cause of biliary obstruction is malignant neoplasm
4. When biliary obstruction cannot be treated surgically, or when surgery is rejected
1. When bile duct stenosis is accompanied by intrahepatic bile duct or hepatic tract
2. If the distance from the distal boundary of the bile duct stenosis to the nipple is within 2cm
3. Subjects with uncontrolled cardiopulmonary disease that is difficult to sleep endoscopy
4. Subjects with uncontrolled coagulation disorder (INR >1.5 or platelet count <50,000 / cmm3)
5. Subjects who are currently receiving antithrombotic treatment but cannot stop or postpone
6. Pregnant women
7. Subjects who have not obtained informed consent
8. Patients who are unable to ERCP due to a deformed anatomy or gastrointestinal obstruction due to previous surgery
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent patency
- Secondary Outcome Measures
Name Time Method Technical success rate;Clinical success rate;Adverse reaction;Survial