Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound
This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Indiana University
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01624363
First received: June 18, 2012
Last updated: April 2, 2013
Last verified: April 2013
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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
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: | April 2, 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 May 22, 2013