Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Ertan Digestive Disease Center - University of Texas Health Science Center
Houston, Texas 77030
Contact:
Nirav Thosani, MD
Nirav.Thosani@uth.tmc.edu

More Details

NCT ID
NCT03421340
Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Elizabeth Kennedy
508-683-4807
Elizabeth.Kennedy@bsci.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.