To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (ERC).
The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Stanford University Medical Center
Stanford, California, United States
University of Colorado Hospital, Denver
Aurora, Colorado, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Ertan Digestive Disease Center - University of Texas Health Science Center
Number of Participants With Complete Stone Clearance
Prospectively compare DSC vs. ERC
Time frame: 30 Days
Rate of Serious Adverse Events
To evaluate all SAEs including death, severity, onset, time to resolution.
Time frame: 30 Days
Radiation Exposure
Total Fluoroscopy time
Time frame: 3 hours
Duration of Procedure
Defined as time from duodenoscope in to completion of stone clearance.
Time frame: 3 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Houston, Texas, United States
Asian Institute of Gastroenterology
Hyderabad, Somajiguda, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Fundazione Policlinico Universitario Agostino Gemelli
Rome, Italy
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand