No registrations found.
ID
Source
Brief title
Health condition
Pancreatobiliary stricture suspicious for malignancy
Pancreatobiliaire stricturen verdacht voor maligniteit
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- Diagnostic performance
- Cellular yield
- Complication rate, such as bleeding, cholangitis or pancreatitis
Study objective
We hypothosize that the sensitivity of the Infinity cytology device (US Endoscopy,Northeast Ohio, USA) is higher compared to the RX Cytology brush (Boston scientific Corporation, Marlborough, MA, USA) in patients with pancreatobiliary stricture suspicious for malignancy.
Study design
T = 0 ERCP
T = 7 days (telephone)
T = 30 days (telephone)
T = 6 months (patient records)
Intervention
During ERCP biliary brushing will be performed with either standard RX cytology brush (group 1) or the Infinity cytology device (group 2).
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5234 |
| NTR-old | NTR5458 |
| Other | METC AMC Amsterdam : METC 2015_240 |