Biliary drainage using a fully covered self-expandable metal stent in patients with malignant distal bile duct obstructio
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0007263
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Anyone who meets all of the following criteria can enroll this study.
1. Adults over 19 years old.
2. unresectable distal biliary malignancy which was radiologically or pathologically diagnosed
3. Expected life expectancy > 3 months based on Karnofsky performance score
4. Patients with informed consent
Exclusion Criteria
1. Surgically altered anatomy except cholecystectomy
2. History of prior biliary metal stenting
3. Coagulopathy (International normalized ratio >1.5, platelet count <50,000)
4. Unsuitable for ERCP
5. Duodenal stricture
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cumulative stent patency rate
- Secondary Outcome Measures
Name Time Method Overall patient survival;overall patient survival rate without stent dysfunction;Functional success rate