Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy

NACompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

March 1, 2022

Study Completion Date

March 1, 2022

Conditions
Biliary StrictureJaundice, Obstructive
Interventions
DEVICE

Biliary brushing with the RX Cytology brush, Boston Scientific

"Biliary brushing during ERCP:~* Performing a dozen back and forth movements in the stenosis~* Bile aspiration if possible, by the catheter of the brush for cytological analysis~* The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2~ * In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)"

DEVICE

Biliary brushing with the Infinity® brush, US Endoscopy

"Biliary brushing during ERCP:~* Performing a dozen back and forth movements in the stenosis~* Bile aspiration if possible, by the catheter of the brush for cytological analysis~* The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2~ * In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)"

Trial Locations (1)

F-94220

Clinique Paris Bercy, Charenton-le-Pont

All Listed Sponsors
lead

Société Française d'Endoscopie Digestive

OTHER

NCT04251013 - Multicenter RCT for BIliary Brushing: RX Cytology, BOSTON vs. Infinity®, US Endoscopy | Biotech Hunter | Biotech Hunter