Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 8
- Primary Endpoint
- Number of Participants With Complete Stone Clearance
Study Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain)
- •Abnormal LFTs
- •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 ≤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
- •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
- •If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable.
- •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.
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion Criteria
- •Potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated
- •Location of the stones in intrahepatic ducts, cystic duct or proximal to strictures
- •Bile duct stricture noted distal to stone on MRCP, which would make extraction without lithotripsy impossible
- •Ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla
- •Patients with prior biliary sphincterotomy
- •Patients with Primary Sclerosing Cholangitis (PSC)
- •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
- •Surgically altered gastro-duodenal luminal anatomy other than prior Billroth I reconstruction, as these would be anticipated to lead to more complicated procedures
- •Coagulopathy or ongoing need for anti-coagulation
Arms & Interventions
ERC Arm
After screening examination and confirmed presence of non-complex bile duct stone by image, patients will be randomly assigned by stratified randomization to Endoscopic Retrograde Cholangioscopy (ERC) treatment.
Intervention: ERC (Device)
DSC Arm
After screening examination and confirmed presence of non-complex bile duct stone by imagine, patients will be randomly assigned by stratified randomization to fluoroscopy/radiation-free direct solitary cholangioscopy (DSC).
Intervention: DSC (Device)
Outcomes
Primary Outcomes
Number of Participants With Complete Stone Clearance
Time Frame: 30 Days
Prospectively compare DSC vs. ERC
Secondary Outcomes
- Radiation Exposure(3 hours)
- Rate of Serious Adverse Events(30 Days)
- Duration of Procedure(3 hours)