Study Results
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View full resultsBasic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2018-09-21
2023-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
ERC
Standard of care stone removal with fluoroscopy.
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).
DSC
Stone removal without fluoroscopy using the SpyGlass device.
Interventions
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DSC
Stone removal without fluoroscopy using the SpyGlass device.
ERC
Standard of care stone removal with fluoroscopy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 ≤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
1. If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable.
2. 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
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Subhash Banerjee, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Nirav Thosani, MD
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Texas Health Sciences
Raj J Shah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Mohan Ramchandani, MD
Role: PRINCIPAL_INVESTIGATOR
Asian Institure of Gastroenterology
Guido Costamagna, MD
Role: PRINCIPAL_INVESTIGATOR
Fundazione Policlinico Universitario
Rungsun Rerknimitr, MD
Role: PRINCIPAL_INVESTIGATOR
King Chulalongkorn Memorial Hospital
Janak N Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System
Mahesh Goenka, MD
Role: PRINCIPAL_INVESTIGATOR
Apollo Gleneagles Hospitals, Kolkata
Locations
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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
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
Countries
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References
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Ridtitid W, Rerknimitr R, Ramchandani M, Lakhtakia S, Shah RJ, Shah JN, Thosani N, Goenka MK, Costamagna G, Wagh MS, Perri V, Peetermans J, Goswamy PG, Liu Z, Yin S, Banerjee S. Endoscopic clearance of non-complex biliary stones using fluoroscopy-free direct solitary cholangioscopy: Initial multicenter experience. DEN Open. 2023 Jun 1;4(1):e241. doi: 10.1002/deo2.241. eCollection 2024 Apr.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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E7131
Identifier Type: -
Identifier Source: org_study_id
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