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Registry and Fluid Banking of Pancreatic Cystic Lesions

This study has been terminated.
(Administratively inactivated)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01769534
First received: January 14, 2013
Last updated: April 13, 2017
Last verified: April 2017
  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: 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.

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 ]

Biospecimen Retention:   Samples Without DNA
Pancreatic cyst fluid

Enrollment: 107
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   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01769534     History of Changes
Other Study ID Numbers: 2487
Study First Received: January 14, 2013
Last Updated: April 13, 2017

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

ClinicalTrials.gov processed this record on April 26, 2017