Cholangioscopic Classification of Bile Duct Lesions

CompletedOBSERVATIONAL
Enrollment

130

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Bile Duct Lesions
Interventions
DEVICE

SpyGlass® choledoscopy

Stage 1: patients included were evaluated using a standard duodenoscope and both SpyGlass® cholangioscopes: First generation, SpyGlass® Direct Visualization System and Second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA) Procedures were performed by one experienced endoscopists with more than 300 ERCP/year (C.R.M). Biopsies were taken in order to correlate to histopathology. Stage 2: patients will be evaluated using a standard duodenoscope and second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA). Procedures will be performed by two experienced endoscopists with more than 300 ERCP/year (C.R.M and M.S.A). Biopsies will be taken in order to correlate to histopathology.

Trial Locations (1)

090505

Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital, Guayaquil

All Listed Sponsors
lead

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

NCT02794987 - Cholangioscopic Classification of Bile Duct Lesions | Biotech Hunter | Biotech Hunter