Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

April 18, 2017 updated by: John DeWitt, Indiana University

Prevalence of Pancreatic Cysts During Routine EUS

The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

Study Overview

Status

Completed

Conditions

Detailed Description

The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)

Study Type

Observational

Enrollment (Actual)

341

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

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46220-5121
        • University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were identified on the day of scheduled endoscopy.

Description

Inclusion Criteria:

  • The inclusion criteria included: patients >18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass.

Exclusion Criteria:

  • Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct
  • Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas
  • Laboratory and/or clinical evidence of ongoing acute pancreatitis
  • Previous pancreatic surgical resection
  • Pregnancy
  • Incarceration
  • High risk for sedation
  • Coagulopathy and/or thrombocytopenia
  • The patients underwent a complete EUS examination of the pancreas.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients undergoing EUS
Patients undergoing EUS for non-pancreatic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Pancreatic Cysts During Routine EUS
Time Frame: 48 months
The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: John M. DeWitt, M.D., Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0906-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results publication

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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