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Non-Complex Biliary Stones DSC vs ERC

Primary Purpose

Biliary Stones

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

DSC

ERC

About this trial

This is an interventional treatment trial for Biliary Stones focused on measuring ERCP, DSC, Spy Glass, Biliary Stones, Choledocholithiasis, Non-Complex, Stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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
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.
Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

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

Sites / Locations

Stanford University Medical Center
University of Colorado Hospital, Denver
Ochsner Clinic Foundation
Ertan Digestive Disease Center - University of Texas Health Science Center
Asian Institute of Gastroenterology
Apollo Gleneagles Hospitals Kolkata
Fundazione Policlinico Universitario Agostino Gemelli
King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

ERC Arm

DSC Arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Complete stone clearance

Prospectively compare DSC vs. ERC

Secondary Outcome Measures

Adverse event evaluation

To evaluate all SAEs including death, severity, onset, time to resolution.

Radiation Exposure

Measure of radiation exposure from duodenoscope in to completion of stone clearance.

Duration of Procedure

Defined as time from duodenoscope in to completion of stone clearance.

Full Information

NCT ID

NCT03421340

First Posted

January 30, 2018

Last Updated

October 19, 2023

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03421340

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 21, 2018 (Actual)

Primary Completion Date

September 18, 2023 (Actual)

Study Completion Date

October 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Stones

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

297 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ERC Arm

Arm Type

Other

Arm Description

Arm Title

DSC Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

DSC

Other Intervention Name(s)

Direct Solitary Cholangioscopy

Intervention Description

Stone removal without fluoroscopy using the SpyGlass device.

Intervention Type

Device

Intervention Name(s)

ERC

Other Intervention Name(s)

Endoscopic Retrograde Cholangiography

Intervention Description

Standard of care stone removal with fluoroscopy.

Primary Outcome Measure Information:

Title

Complete stone clearance

Description

Prospectively compare DSC vs. ERC

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Adverse event evaluation

Description

To evaluate all SAEs including death, severity, onset, time to resolution.

Time Frame

2 years

Title

Radiation Exposure

Description

Measure of radiation exposure from duodenoscope in to completion of stone clearance.

Time Frame

2 years

Title

Duration of Procedure

Description

Defined as time from duodenoscope in to completion of stone clearance.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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 Exclusion Criteria: 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

Overall Study Officials: