- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00880633
Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective
February 16, 2011 updated by: Indiana University
EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review
The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Retrospective review of patients who have already undergone an EUS at this institution.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
April 13, 2009
First Submitted That Met QC Criteria
April 13, 2009
First Posted (Estimate)
April 14, 2009
Study Record Updates
Last Update Posted (Estimate)
February 17, 2011
Last Update Submitted That Met QC Criteria
February 16, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0703-58
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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