Non-Complex Biliary Stones DSC vs ERC

Not Applicable

Completed

• Conditions: Biliary Stones
• Interventions: Device: DSC; Device: ERC

• Registration Number: NCT03421340
• Lead Sponsor: Boston Scientific Corporation

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 Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-05
• Study Start: 2018-09-21
• Primary Completion: 2023-09-18
• Study Completion: 2023-10-08
• Status Verified: 2024-09
• Results First Submitted: 2024-09-04
• Results First Submitted QC: 2024-11-07
• Results First Posted: 2024-11-08
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSC Arm	DSC	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).
ERC Arm	ERC	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Stone Clearance	30 Days	Prospectively compare DSC vs. ERC

Secondary Outcome Measures

Name	Time	Method
Rate of Serious Adverse Events	30 Days	To evaluate all SAEs including death, severity, onset, time to resolution.
Radiation Exposure	3 hours	Total Fluoroscopy time
Duration of Procedure	3 hours	Defined as time from duodenoscope in to completion of stone clearance.

Trial Locations

Locations (8)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

University of Colorado Hospital, Denver; 🇺🇸 Aurora, Colorado, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Fundazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy

Ertan Digestive Disease Center - University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

King Chulalongkorn Memorial Hospital; 🇹🇭 Pathum Wan, Bangkok, Thailand

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Somajiguda, India

Apollo Gleneagles Hospitals Kolkata; 🇮🇳 Kolkata, West Bengal, India