NCT00880633

Brief Summary

The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2007

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

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

April 13, 2009

Last Update Submit

February 16, 2011

Conditions

Periampullary Neoplasms

Keywords

EUSperiampullary neoplasms

Outcome Measures

Primary Outcomes (1)

  • The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts

Eligibility Criteria

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

Retrospective review of patients who have already undergone an EUS at this institution.

You may qualify if:

  • Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.
  • Patients with and without biliary stents will be included.

You may not qualify if:

  • Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

April 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations

US(1)