Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study
Phase 2
- Conditions
- bile duct stone
- Registration Number
- JPRN-UMIN000026951
- Lead Sponsor
- Teikyo University Mizonokuchi Hospital, Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1) previous gastrectomy,except for Billroth-I reconstruction 2) biliary stenosis 3) recurrent stone in patients with previous ES(widely opened biliary orifice) 4) age younger than 20 years 5) bleeding tendency a) platelet count less than 50,000/mm3, b) international normalized ratio (INR)[1.5] c) patients receiving anticoagulants d) patients with underlying diseases associated with bleeding tendency and coagulopathy 6) unable or not wishing to give informed consent 7) judged by a physician to be inappropriate for inclusion in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete stone clearance rate at single endocopic session
- Secondary Outcome Measures
Name Time Method adverse events related to the procedure and their occurrence rates