search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number22827
- NTR NumberNTR5458
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-sep-2015
- Secondary IDsMETC 2015_240 METC AMC Amsterdam
- Public TitleERCP BRush cytology of pancreatobiliary strictures Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial
- Scientific TitleERCP BRush cytology of pancreatobiliary strictures Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial
- ACRONYMBRIX
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedPancreas, Bile ducts, Malignancy
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2015
- planned closingdate15-okt-2016
- Target number of participants106
- InterventionsDuring ERCP biliary brushing will be performed with either standard RX cytology brush (group 1) or the Infinity cytology device (group 2).
- Primary outcomeThe 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
- TimepointsT = 0 ERCP
T = 7 days (telephone)
T = 30 days (telephone)
T = 6 months (patient records)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Lekkerkerker
- CONTACT for SCIENTIFIC QUERIES S. Lekkerkerker
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD2-sep-2015 - 23-dec-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl