Diagnostic approach using ERCP-guided transpapillary forceps biopsy or EUS-guided fine-needle aspiration biopsy according to the nature of suspected malignant biliary stricture
Phase 4
- Conditions
- Malignant bile duct stricture
- Registration Number
- JPRN-UMIN000016886
- Lead Sponsor
- SoonChunHyang University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 174
Inclusion Criteria
Not provided
Exclusion Criteria
(1) underlying pancreatobiliary disease without clinical findings suggestive of malignancy (e.g., primary biliary cirrhosis or postoperative biliary stricture), (2) the presence of any contraindication for ERCP, (3) coagulopathy (international normalized ratio >1.5 or platelet count <80,000/mm3 (4) difficulty to perform ERCP due to altered gastrointestinal anatomy or a significant duodenal obstruction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the accuracy of the diagnostic approach using ERCP-guided TPB and EUS-FNAB according to the type of biliary stricture in patients with suspected MBS
- Secondary Outcome Measures
Name Time Method the accuracy of initial TPB, technical failure and adverse event rates of ERCP-guided TPB and EUS-FNAB