Health Condition 1: null- Patients with confirmed non-complex bile duct stones.
Conditions
Interventions
Intervention1: SpyGlassâ?¢
Direct
Visualization
System
(DS): -SpyGlassâ?¢ DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScopeâ?¢ DS Acce
Sponsors
Boston Scientific Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years or older 2. Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain) 3. Abnormal LFTs 4. Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. If stones not seen on imaging (US, CT) the bile duct diameter should be less than or equal to 12 mm - Given the poor sensitivity (approximately 20%) for biliary stones of CT and US, the diameter of the dilated CBD is used as a surrogate for largest stone diameter 5. Availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging a. If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable. b. If the probability of stones is either intermediate or low per investigator assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm presence of stones. 6. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated 2. Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures 3. Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible 4. Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla 5. Patients with prior biliary sphincterotomy 6. Patients with Primary Sclerosing Cholangitis (PSC) 7. Acute pancreatitis, defined as abdominal pain and serum concentration of pancreatic enzymes [lipase (required), amylase (optional)] three or more times the upper limit of normal 8. Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures 9. Coagulopathy or ongoing need for anti-coagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is complete stone clearance by extraction of bile duct stones from the common bile duct (CBD) into duodenum as determined by fluoroscopy free cholangioscopy in the DSC arm and by cholangiography in the ERC arm.Timepoint: Primary objectives and secondary objectives are assessed post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of procedure defined as time from duodenoscope in to completion of stone clearance, not including the validation DSC procedure in ERC arm and ERC procedure in DSC arm.Timepoint: Primary objectives and secondary objectives are assessed post procedure.;Evaluation of all serious adverse events (SAEs) including all deaths (related and unrelated), severity, onset, time to resolution related to the DSC devices and/or procedure and/or the ERC procedure through 30 days post procedure. Timepoint: Primary objectives and secondary objectives are assessed post procedure.;Radiation exposure to the patient (total fluoroscopy time, total radiation dose, Dose Area Product (DAP), effective dose), from duodenoscope in to completion of stone clearance, not including the validation DSC procedure in ERC arm and ERC procedure in DSC arm.Timepoint: Primary objectives and secondary objectives are assessed post procedure. | — |
Countries
India, Italy, Japan, Netherlands, Thailand, United States of America
Contacts
Public ContactDr Mohan Ramchandani
Asian Institute of Gastroenterology
Outcome results
None listed