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Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00880633
First received: April 13, 2009
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition
Periampullary Neoplasms

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts [ Designated as safety issue: No ]

Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880633

Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Dr. Julia LeBlanc, Indiana University
ClinicalTrials.gov Identifier: NCT00880633     History of Changes
Other Study ID Numbers: 0703-58
Study First Received: April 13, 2009
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
EUS
periampullary neoplasms

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013