NCT01769534

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

4.1 years

First QC Date

January 14, 2013

Last Update Submit

December 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • To validate the Sendai criteria prospectively in patients with pancreatic cysts.

    up to 1 year

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Centrer at OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreatic cyst fluid

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • John T Maple, M.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations