ERCP BRush cytology of pancreatobiliary strictures – Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial
- Conditions
- Pancreatobiliary stricture suspicious for malignancyPancreatobiliaire stricturen verdacht voor maligniteit
- Registration Number
- NL-OMON25595
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 106
Inclusion Criteria
‐ Patients with pancreatobiliary stricture suspicious for malignancy
• Who are planned to undergo ERCP with biliary brush cytology
Exclusion Criteria
‐ Inability to cannulate the papilla
‐ Hilar biliary obstruction, defined as stenosis located within 2 cm of the hilum
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is the difference in sensitivity of brush cytology between the standard RX cytology brush and the Infinity cytology device.
- Secondary Outcome Measures
Name Time Method - Diagnostic performance<br /><br>- Cellular yield <br /><br>- Complication rate, such as bleeding, cholangitis or pancreatitis