A prospective randomized comparative study of a novel anti-reflux metal stent versus partial covered metal stent in patients with inoperable distal malignant biliary strictures
Not Applicable
- Conditions
- Inoperable distal malignant biliary stircutres 1) Common bile duct cancer 2) Pancreatic head cancer 3) Gallbladder cancer 4) Other metastatic malignant biliary strictures
- Registration Number
- JPRN-UMIN000012734
- Lead Sponsor
- SoonChunHyang University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Not provided
Exclusion Criteria
1) Refusal of this study 2) Plan for curative or palliative surgery 3) Stricture in distance within 2 cm from the bifurcation of bile duct 4) Risk of bleeding: PT-INR > 1.5, normal 0.85-1.25 or platelet count < 80,000/mm3, normal 150,000-450,000/mm3 5) Pregnant or breast-feeding women 6) Performance status < 3 (scales of the Eastern Cooperative Oncology Group)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method