Non-Complex Biliary Stones DSC vs ERC

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)

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).

Study Overview

• Status: Completed
• Conditions: Biliary Stones
• Intervention / Treatment: Device: ERC; Device: DSC

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 Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Martinek; Phone Number: 508-683-6579; Email: stefanie.martinek@bsci.com
• Study Contact Backup: Name: Pooja Goswamy; Email: Pooja.Goswamy@bsci.com

Study Locations

• India
  • Somajiguda
    • Hyderabad, Somajiguda, India, 500082
      • Asian Institute Of Gastroenterology
  • West Bengal
    • Kolkata, West Bengal, India, 700054
      • Apollo Gleneagles Hospitals Kolkata
• Italy
  • Rome, Italy, 00168
    • Fundazione Policlinico Universitario Agostino Gemelli
• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • King Chulalongkorn Memorial Hospital
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital, Denver
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77030
      • Ertan Digestive Disease Center - University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Electroscopic Retrograde Cholangioscopy (ERC) treatment.	Device: ERC; Standard of care stone removal with fluoroscopy.; Other Names: Endoscopic Retrograde Cholangiography
Other: 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).	Device: DSC; Stone removal without fluoroscopy using the SpyGlass device.; Other Names: Direct Solitary Cholangioscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete stone clearance	Prospectively compare DSC vs. ERC	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event evaluation	To evaluate all SAEs including death, severity, onset, time to resolution.	2 years
Radiation Exposure	Measure of radiation exposure from duodenoscope in to completion of stone clearance.	2 years
Duration of Procedure	Defined as time from duodenoscope in to completion of stone clearance.	2 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): October 8, 2023

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ERCP; Choledocholithiasis; Stones; DSC; Spy Glass; Biliary Stones; Non-Complex
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: E7131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes