Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

NCT ID: NCT01678391

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Common Bile Duct Gall Stones

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with common bile duct stones.

Common bile duct stone removal without fluoroscopy

Group Type EXPERIMENTAL

Common bile duct stone removal without fluoroscopy.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Janak Shah, MD

Director of Pancreatic and Biliary Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janak Shah, MD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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California Pacific Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12447259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18226705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16546022 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27040099 (View on PubMed)

Other Identifiers

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2012.065-1

Identifier Type: -

Identifier Source: org_study_id

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