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Registry and Fluid Banking of Pancreatic Cystic Lesions

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ClinicalTrials.gov Identifier: NCT01769534
Recruitment Status : Terminated (Administratively inactivated)
First Posted : January 16, 2013
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.

Condition or disease
Pancreatic Cysts

Detailed Description:
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).

Study Type : Observational [Patient Registry]
Actual Enrollment : 107 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.
Study Start Date : June 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016



Primary Outcome Measures :
  1. To validate the Sendai criteria prospectively in patients with pancreatic cysts. [ Time Frame: up to 1 year ]

Biospecimen Retention:   Samples Without DNA
Pancreatic cyst fluid


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).
Criteria

Inclusion Criteria:

  • consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts.

Exclusion Criteria:

  • Patient unable to give informed consent
  • age<18 or >85, patients with clinically suspected pseudocysts.

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): NCT01769534


Locations
United States, Oklahoma
Endoscopy Centrer at OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: John T Maple, M.D. University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01769534     History of Changes
Other Study ID Numbers: 2487
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases