NCT01678391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

August 29, 2012

Last Update Submit

July 25, 2016

Conditions

Common Bile Duct Gall Stones

Outcome Measures

Primary Outcomes (1)

  • Successful removal of all stones from the bile duct without the use of fluoroscopy.

    Up to 24 hours.

Study Arms (1)

Patients with common bile duct stones.

EXPERIMENTAL

Common bile duct stone removal without fluoroscopy

Procedure: Common bile duct stone removal without fluoroscopy.

Interventions

Common bile duct stone removal without fluoroscopy.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.

Patients with common bile duct stones.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Related Publications (4)

  • 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.

    PMID: 12447259BACKGROUND

  • 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.

    PMID: 18226705BACKGROUND

  • 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.

    PMID: 16546022BACKGROUND

  • 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.

    PMID: 27040099DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Janak Shah, MD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pancreatic and Biliary Endoscopy

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 5, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(1)