Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Common Bile Duct Gall Stones Clinical Trial

Official title:

Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678391
• Other study ID #: 2012.065-1
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: July 25, 2016
• Start date: August 2012
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Common Bile Duct Gall Stones
• Gallstones

Intervention

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.

Locations

Country	Name	City	State
United States	California Pacific Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	Northwestern University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful removal of all stones from the bile duct without the use of fluoroscopy.		Up to 24 hours.	No