NCT00894348

Brief Summary

To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

4.9 years

First QC Date

May 5, 2009

Last Update Submit

March 29, 2017

Conditions

Biliary Stricture

Keywords

ERCPPositive Biliary Brush Cytology

Outcome Measures

Primary Outcomes (1)

  • To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing an ERCP for evaluation of biliary strictures

You may qualify if:

  • ERCP Patients

You may not qualify if:

  • Non ERCP Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Mansour Parsi, M.D.

    Staff Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 7, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)