Non-Complex Biliary Stones DSC vs ERC

NCT03421340 | Completed Results FDA Device

• 1 other identifier: E7131
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 8

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).

Conditions

Biliary Stones

Keywords

ERCP; DSC; Spy Glass; Biliary Stones; Choledocholithiasis; Non-Complex; Stones

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Stone Clearance

  Prospectively compare DSC vs. ERC

  30 Days

Secondary Outcomes (3)

• Rate of Serious Adverse Events

  30 Days

• Radiation Exposure

  3 hours

• Duration of Procedure

  3 hours

Study Arms (2)

ERC Arm

OTHER

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.

Device: ERC

DSC Arm

OTHER

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).

Device: DSC

Interventions

DSC DEVICE

Stone removal without fluoroscopy using the SpyGlass device.

Also known as: Direct Solitary Cholangioscopy

DSC Arm

ERC DEVICE

Standard of care stone removal with fluoroscopy.

Also known as: Endoscopic Retrograde Cholangiography

ERC Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (8)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Hospital, Denver

Aurora, Colorado, 80045, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Ertan Digestive Disease Center - University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Asian Institute of Gastroenterology

Hyderabad, Somajiguda, 500082, India

Location

Apollo Gleneagles Hospitals Kolkata

Kolkata, West Bengal, 700054, India

Location

Fundazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (2)

• Banerjee S, Goenka MK, Ramchandani M, Shah RJ, Lakhtakia S, Ridtitid W, Shah JN, Thosani N, Wagh MS, Costamagna G, Peetermans JA, Rousseau MJ, Rerknimitr R. Fluoroscopy-free Direct Solitary Cholangioscopy versus Endoscopic Retrograde Cholangiography for Clearance of Noncomplex Biliary Stones: A Noninferiority Randomized Controlled Trial. Gastrointest Endosc. 2026 Jan 16:S0016-5107(25)02534-9. doi: 10.1016/j.gie.2025.12.283. Online ahead of print.

  PMID: 41548725 DERIVED

• 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.

  PMID: 37273518 DERIVED

MeSH Terms

Conditions

Cholecystolithiasis; Choledocholithiasis; Calculi

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pooja Goswamy
• Organization: Boston Scientific

pooja.goswamy@bsci.com

15086834335

Study Officials

• Subhash Banerjee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Nirav Thosani, MD

  Univeristy of Texas Health Sciences

  PRINCIPAL INVESTIGATOR

• Raj J Shah, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Mohan Ramchandani, MD

  Asian Institure of Gastroenterology

  PRINCIPAL INVESTIGATOR

• Guido Costamagna, MD

  Fundazione Policlinico Universitario

  PRINCIPAL INVESTIGATOR

• Rungsun Rerknimitr, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Janak N Shah, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

• Mahesh Goenka, MD

  Apollo Gleneagles Hospitals, Kolkata

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: September 21, 2018
• Primary Completion: September 18, 2023
• Study Completion: October 8, 2023
• Last Updated: January 17, 2025
• Results First Posted: November 8, 2024

Record last verified: 2024-09

Locations

US (4); IT (1); IN (2); TH (1)