Registry and Fluid Banking of Pancreatic Cystic Lesions

This study is currently recruiting participants.
Verified January 2013 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01769534
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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


Condition
Pancreatic Cysts

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To validate the Sendai criteria prospectively in patients with pancreatic cysts. [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Pancreatic cyst fluid


Estimated Enrollment: 3
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769534

Contacts
Contact: John T Maple, D.O. 4052715428 john-maple@ouhsc.edu
Contact: Carol Clark, R.N. 4052715428 carol-clark@ouhsc.edu

Locations
United States, Oklahoma
Endoscopy Centrer at OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Carol Clark, R.N    405-271-5428    carol-clark@ouhsc.edu   
Contact: John T Maple, D.O    4052715428    john-maple@ouhsc.edu   
Sub-Investigator: Shih-kuang S Hong, M.D.         
Sub-Investigator: William M Tierney, M.D.         
Sub-Investigator: Courtney Houchen, M.D.         
Sub-Investigator: Hanumantha R Ancha, M.D.         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: John T Maple, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01769534     History of Changes
Other Study ID Numbers: GI-16502
Study First Received: January 14, 2013
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014