Clinical trial NCT03421340: Non-Complex Biliary Stones DSC vs ERC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Stones
Keywords: ERCP
DSC
Spy Glass
Biliary Stones
Choledocholithiasis
Non-Complex
Stones
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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 ≤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:

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

Primary outcomes:
measure: Number of Participants With Complete Stone Clearance
timeFrame: 30 Days
Secondary outcomes:
measure: Rate of Serious Adverse Events
timeFrame: 30 Days
measure: Radiation Exposure
timeFrame: 3 hours
measure: Duration of Procedure
timeFrame: 3 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital, Denver
state: Colorado
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Houston
country: United States
facility: Ertan Digestive Disease Center - University of Texas Health Science Center
state: Texas
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Somajiguda
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
state: West Bengal
city: Rome
country: Italy
facility: Fundazione Policlinico Universitario Agostino Gemelli
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Stanford University
name: Subhash Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Texas Health Sciences
name: Nirav Thosani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Raj J Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institure of Gastroenterology
name: Mohan Ramchandani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundazione Policlinico Universitario
name: Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Chulalongkorn Memorial Hospital
name: Rungsun Rerknimitr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ochsner Health System
name: Janak N Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Gleneagles Hospitals, Kolkata
name: Mahesh Goenka, MD
role: PRINCIPAL_INVESTIGATOR
References: