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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50220

Enrollment

112

Registered

2016-01-14

Start date

2016-06-13

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatobiliary strictures

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the difference in sensitivity of brush cytology between the standard RX cytology brush and the Infinity cytology device	—

Secondary

Measure	Time frame
Diagnostic performance Cellular yield Complication rate, such as bleeding, cholangitis or pancreatitis	—

Countries

Netherlands

Outcome results