Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Phase 2
- Conditions
- Resectable malignant hilar biliary obstruction
- Registration Number
- JPRN-UMIN000025463
- Lead Sponsor
- Japanese foundation for cancer research, Cancer institute hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of radiotherapy, chemotherapy or immunotherapy for malignant disease before starting the study treatment 2. Preoperative biliary drainage is not needed. 3. PTBD has been performed at previous hospital. 4. Severe complications such as intestinal pneumonia, pulmonary fibrosis, and heart failure 5. Psychosis or severe mental disorder 6. Pregnant or lactating female and patients who is considering pregnancy 7. Inappropriate patients for entry on this study in the judgement of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method