Registry and Fluid Banking of Pancreatic Cystic Lesions
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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. |
- 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) |
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 |
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).
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| Contact: John T Maple, D.O. | 4052715428 | john-maple@ouhsc.edu |
| Contact: Carol Clark, R.N. | 4052715428 | carol-clark@ouhsc.edu |
| 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. | |
| 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 June 17, 2013