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

Tracking Information
First Received Date ^ICMJE	April 13, 2009
Last Updated Date	February 16, 2011
Start Date ^ICMJE	April 2007
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2009)	The presence of a biliary stent decreases EUS staging accuracy due to the intervening shadow artifacts [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00880633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective
Official Title ^ICMJE	EUS Staging Accuracy of Periampullary Neoplasms: a Retrospective Review
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Retrospective review of patients who have already undergone an EUS at this institution.
Condition ^ICMJE	Periampullary Neoplasms
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	February 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00880633
Other Study ID Numbers ^ICMJE	0703-58
Has Data Monitoring Committee	No
Responsible Party	Dr. Julia LeBlanc, Indiana University
Study Sponsor ^ICMJE	Indiana University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Indiana University
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top