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…
ID
Bron
Verkorte titel
Aandoening
Pancreatobiliary stricture suspicious for malignancy
Pancreatobiliaire stricturen verdacht voor maligniteit
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint is the difference in sensitivity of brush cytology between the standard RX cytology brush and the Infinity cytology device.
Doel van het onderzoek
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.
Onderzoeksopzet
T = 0 ERCP
T = 7 days (telephone)
T = 30 days (telephone)
T = 6 months (patient records)
Onderzoeksproduct en/of interventie
During ERCP biliary brushing will be performed with either standard RX cytology brush (group 1) or the Infinity cytology device (group 2).
Publiek
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Wetenschappelijk
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
‐ 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
‐ 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5234 |
| NTR-old | NTR5458 |
| Ander register | METC AMC Amsterdam : METC 2015_240 |