Registry and Fluid Banking of Pancreatic Cystic Lesions

Pancreatic Cysts Clinical Trial

Official title:

Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01769534
• Other study ID #: 2487
• Status: Terminated
• Phase: N/A
• First received: January 14, 2013
• Last updated: December 15, 2017
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cyst
• Pancreatic Cysts

Locations

Country	Name	City	State
United States	Endoscopy Centrer at OU Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the Sendai criteria prospectively in patients with pancreatic cysts.		up to 1 year