Back to resultsFeasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Primary Purpose
Common Bile Duct Gall Stones
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Common bile duct stone removal without fluoroscopy.
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Gall Stones
Eligibility 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
Sites / Locations
- California Pacific Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with common bile duct stones.
Arm Description
Common bile duct stone removal without fluoroscopy
Outcomes
Primary Outcome Measures
Successful removal of all stones from the bile duct without the use of fluoroscopy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01678391
First Posted
August 29, 2012
Last Updated
July 25, 2016
Sponsor
California Pacific Medical Center Research Institute
Collaborators
University of California, Los Angeles, Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01678391
Brief Title
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Official Title
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute
Collaborators
University of California, Los Angeles, Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Gall Stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with common bile duct stones.
Arm Type
Experimental
Arm Description
Common bile duct stone removal without fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Common bile duct stone removal without fluoroscopy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful removal of all stones from the bile duct without the use of fluoroscopy.
Time Frame
Up to 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janak Shah, MD
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12447259
Citation
Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
Results Reference
background
PubMed Identifier
18226705
Citation
Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.
Results Reference
background
PubMed Identifier
16546022
Citation
Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.
Results Reference
background
PubMed Identifier
27040099
Citation
Shah JN, Bhat YM, Hamerski CM, Kane SD, Binmoeller KF. Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video). Gastrointest Endosc. 2016 Nov;84(5):764-769. doi: 10.1016/j.gie.2016.03.1485. Epub 2016 Mar 31.
Results Reference
derived
Learn more about this trial
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
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