ERCP brush cytology of pancreatobiliary strictures - Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial

Completed

• Conditions: 10019815; Pancreatobiliary strictures; extrahepatic stricture; 10018008; 10004606

• Registration Number: NL-OMON50220
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

* Patients with pancreatobiliary stricture suspicious for malignancy
• Who are planned to undergo ERCP with biliary brush cytology
OR
• Who are planned to undergo ERCP with biliary stent placement for (suspected)
malignant strictures
* >=18 years old
* Written informed consent

Exclusion Criteria

* Inability to cannulate the papilla
* Hilar biliary obstruction, defined as stenosis located within 2 cm of the
hilum
* Not fulfilling standard criteria to undergo ERCP with biliary brush according
to local guidelines

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in sensitivity of brush cytology<br /><br>between the standard RX cytology brush and the Infinity cytology device</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Diagnostic performance<br /><br>Cellular yield<br /><br>Complication rate, such as bleeding, cholangitis or pancreatitis</p><br>