Pancreatobiliary stricture suspicious for malignancy Pancreatobiliaire stricturen verdacht voor maligniteit
Conditions
Interventions
During ERCP biliary brushing will be performed with either standard RX cytology brush (group 1) or the Infinity cytology device (group 2).
Sponsors
Academic Medical Center Amsterdam
Eligibility
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 | — |
Contacts
Public ContactS. Lekkerkerker
Dept. of Gastroenterology and Hepatology Academic Medical Center Meibergdreef 9, C2-310
Outcome results
None listed