Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

This study is currently recruiting participants.
Verified March 2014 by California Pacific Medical Center Research Institute
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: March 24, 2014
Last verified: March 2014

August 29, 2012
March 24, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01678391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Common Bile Duct Gall Stones
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.
Experimental: Patients with common bile duct stones.
Common bile duct stone removal without fluoroscopy
Intervention: Procedure: Common bile duct stone removal without fluoroscopy.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Janak Shah, M.D. 415-600-1151
Contact: Steve Kane 415-600-1151 kanesd@sutterhealth.org
United States
 
NCT01678391
2012.065-1
No
Janak Shah, MD, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
  • University of California, Los Angeles
  • Northwestern University
Principal Investigator: Janak Shah, MD California Pacific Medical Center
California Pacific Medical Center Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP