NCT01525355

Brief Summary

Performing an EUS prior to ERCP in the setting of a positive intraoperative cholangiogram will identify and risk stratify patients for the presence of CBD stones and strictures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

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

October 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2016

Completed
Last Updated

November 7, 2017

Status Verified

April 1, 2017

Enrollment Period

5.7 years

First QC Date

January 30, 2012

Last Update Submit

November 3, 2017

Conditions

CalculiStenosis of Bile Duct

Keywords

EUSERCPIntraoperative cholangiogramCholecystectomyCommon Bile Duct StonesStricturesStenosisDuodenumDilated Bile ductNon-filling of the duodenum by contrast

Outcome Measures

Primary Outcomes (1)

  • Bile Duct

    Stone seen by EUS confirmed by ERCP

    2 years

Secondary Outcomes (5)

  • Lesions

    2 Years

  • Bile duct

    2 years

  • Diverticulum

    2 years

  • ERCP

    2 years

  • ERCP

    2 years

Study Arms (1)

EUS prior to ERCP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have gone an uncomplicated cholesytectomy and determined to have a "positive intraoperative cholangiogram" within one month of presentation to Wake Forest Baptist Health.

You may qualify if:

  • Subjects must be able to review and sign informed consent
  • Cholecystectomy must have been performed within one month of enrollment
  • Positive intraoperative cholangiogram
  • Stone
  • Multiple Stones
  • Stenosis
  • "non filling" of duodenum
  • Dilated bile duct

You may not qualify if:

  • Cannot give and sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

CalculiConstriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • John A Evans, MD

    Wake Forest University Baptist Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 2, 2012

Study Start

October 1, 2010

Primary Completion

June 7, 2016

Study Completion

June 7, 2016

Last Updated

November 7, 2017

Record last verified: 2017-04

Locations

US(1)