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Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624363
First Posted: June 20, 2012
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John DeWitt, Indiana University
  Purpose
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.

Condition
Pancreatic Cysts

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Pancreatic Cysts During Routine EUS

Further study details as provided by John DeWitt, Indiana University:

Primary Outcome Measures:
  • 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 .


Enrollment: 341
Study Start Date: September 2009
Study Completion Date: June 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing EUS
Patients undergoing EUS for non-pancreatic treatment.

Detailed Description:
The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients were identified on the day of scheduled endoscopy.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624363


Locations
United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46220-5121
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: John M. DeWitt, M.D. Indiana University
  More Information

Publications:
Responsible Party: John DeWitt, Director, Endoscopic Ultrasound, Indiana University
ClinicalTrials.gov Identifier: NCT01624363     History of Changes
Other Study ID Numbers: 0906-23
First Submitted: June 18, 2012
First Posted: June 20, 2012
Results First Submitted: May 3, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results publication

Keywords provided by John DeWitt, Indiana University:
Pancreatic cysts incidentally found during EUS

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases