Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 15, 2015

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Biliary Stricture
Interventions
DEVICE

SpyGlass DS Cholangioscopy

SpyGlass DS Cholangioscopy includes a 10 French diameter single use digital cholangioscope and a light source with the digital sensor. During ERCP with cholangioscopic exam, the cholangioscope would be first inserted through the working channel of the duodenoscope and subsequently passed into the bile duct for direct visualization of the bile duct mucosa. The visual impression (VI) of the biliary stricture will be assessed. Tissue acquisition of the biliary stricture will be performed by cholangioscopy directed biopsy (CDBx), and conventional brush cytology with or without intraductal biopsy.

Trial Locations (1)

Unknown

Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER

NCT03307382 - Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures | Biotech Hunter | Biotech Hunter