Non-Complex Biliary Stones DSC vs ERC

Biliary Stones Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421340
• Other study ID #: E7131
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: October 8, 2023

Study information

• Verified date: October 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: October 8, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stones
• Calculi
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• DSC
Stone removal without fluoroscopy using the SpyGlass device.
• ERC
Standard of care stone removal with fluoroscopy.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Somajiguda
India	Apollo Gleneagles Hospitals Kolkata	Kolkata	West Bengal
Italy	Fundazione Policlinico Universitario Agostino Gemelli	Rome
Thailand	King Chulalongkorn Memorial Hospital	Pathum Wan	Bangkok
United States	University of Colorado Hospital, Denver	Aurora	Colorado
United States	Ertan Digestive Disease Center - University of Texas Health Science Center	Houston	Texas
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  India,  Italy,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete stone clearance	Prospectively compare DSC vs. ERC	2 years
Secondary	Adverse event evaluation	To evaluate all SAEs including death, severity, onset, time to resolution.	2 years
Secondary	Radiation Exposure	Measure of radiation exposure from duodenoscope in to completion of stone clearance.	2 years
Secondary	Duration of Procedure	Defined as time from duodenoscope in to completion of stone clearance.	2 years