Diagnostic Accuracy Of Different Cholangioscopy-Guided Biopsy Techniques For The Diagnosis Of Indeterminate Biliary Strictures
- Conditions
- Indeterminate biliary stricture
- Registration Number
- NL-OMON25153
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Male or female > 18 years old
- Presence of an indeterminate biliary stricture, defined as:
1. A bile duct stricture or filling defect of indeterminate nature after previous laboratory work-up, abdominal imaging (MRI, CT, endoscopic ultrasound) or ERCP, and/or;
2. Negative or inconclusive cytology or histology after ERCP with brush cytology or intra-ductal biopsies, and/or;
3. Despite benign cytology or histology findings persistent strong suspicion of a malignant aetiology based on clinical symptoms such as abdominal pain, unexpected weight loss, loss of appetite and obstructive jaundice.
- Written informed consent
- Contraindication for ERCP or SOC (i.e. suspicion of ascending cholangitis or of acute pancreatitis)
- Contraindication for biopsy (i.e. known coagulation disorder)
- No written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity and accuracy
- Secondary Outcome Measures
Name Time Method Adverse events