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Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

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ClinicalTrials.gov Identifier: NCT01624363
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
John DeWitt, Indiana University

Study Description
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Brief Summary:
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 or disease
Pancreatic Cysts

Detailed Description:
The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)
Study Design
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Study Type : Observational
Actual Enrollment : 341 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Pancreatic Cysts During Routine EUS
Study Start Date : September 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015
Groups and Cohorts
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Group/Cohort
Patients undergoing EUS
Patients undergoing EUS for non-pancreatic treatment.


Outcome Measures
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Primary Outcome Measures :
  1. 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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46220-5121
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: John M. DeWitt, M.D. Indiana University
More Information
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Publications:

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Responsible Party: John DeWitt, Director, Endoscopic Ultrasound, Indiana University
ClinicalTrials.gov Identifier: NCT01624363    
Other Study ID Numbers: 0906-23
First Posted: June 20, 2012    Key Record Dates
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:
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Cysts
Pancreatic Cyst
Neoplasms
 Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases