Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01624363
First received: June 18, 2012
Last updated: November 6, 2013
Last verified: April 2013
  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 Intervention
Pancreatic Cysts
Other: Diagnosis of a previously undetected pancreatic cyst

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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Prevalence of Pancreatic Cysts During Routine EUS [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    Cross-sectional imaging identifies cystic neoplasms in up to 1.2% of the general population. However, data from an autopsy series reports pancreatic cysts in up to 24% of patients.EUS can identify small cysts that are not seen on CT scan, MRI or other cross sectional imaging we hypothesize that pancreatic cysts are present between 1.2 and 24% of the population, with rates varying by variables such as age and a previous diagnosis of pancreatitis. The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .

  • The prevalence of pancreatic cysts incidentally found via EUS. [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients undergoing EUS
Patients undergoing EUS for non-pancreatic treatment.
Other: Diagnosis of a previously undetected pancreatic cyst
patients identified to have a pancreatic cyst, will need to be followed via imaging studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624363

Contacts
Contact: Kathleen McGreevy, RN 317-944-5392 kmcgreev@iupui.edu

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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01624363     History of Changes
Other Study ID Numbers: 0906-23
Study First Received: June 18, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 15, 2014