Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Los Angeles
Northwestern University
Information provided by (Responsible Party):
Janak Shah, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01678391
First received: August 29, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.


Condition Intervention
Common Bile Duct Gall Stones
Procedure: Common bile duct stone removal without fluoroscopy.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Successful removal of all stones from the bile duct without the use of fluoroscopy. [ Time Frame: Up to 24 hours. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with common bile duct stones.
Common bile duct stone removal without fluoroscopy
Procedure: Common bile duct stone removal without fluoroscopy.
ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients able to give informed consent
  • Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones

Exclusion Criteria:

  • Patients with >3 bile duct stones or with any stone >12mm on EUS
  • Patients with no bile duct stones on EUS
  • Patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy)
  • Patients who are pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678391

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
University of California, Los Angeles
Northwestern University
Investigators
Principal Investigator: Janak Shah, MD California Pacific Medical Center
  More Information

Publications:
Responsible Party: Janak Shah, MD, Director of Pancreatic and Biliary Endoscopy, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01678391     History of Changes
Other Study ID Numbers: 2012.065-1
Study First Received: August 29, 2012
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Calculi
Gallstones
Cholelithiasis
Cholecystolithiasis
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases

ClinicalTrials.gov processed this record on July 31, 2014