NCT01624363

Brief Summary

The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
341

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

June 18, 2012

Results QC Date

May 3, 2016

Last Update Submit

April 18, 2017

Conditions

Keywords

Pancreatic cysts incidentally found during EUS

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Pancreatic Cysts During Routine EUS

    The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .

    48 months

Study Arms (1)

Patients undergoing EUS

Patients undergoing EUS for non-pancreatic treatment.

Eligibility Criteria

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

Patients were identified on the day of scheduled endoscopy.

You may not qualify if:

  • Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct
  • Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas
  • Laboratory and/or clinical evidence of ongoing acute pancreatitis
  • Previous pancreatic surgical resection
  • Pregnancy
  • Incarceration
  • High risk for sedation
  • Coagulopathy and/or thrombocytopenia
  • The patients underwent a complete EUS examination of the pancreas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Indianapolis, Indiana, 46220-5121, United States

Location

Related Publications (1)

  • Sey MS, Teagarden S, Settles D, McGreevy K, Cote GA, Sherman S, McHenry L, LeBlanc JK, Al-Haddad M, DeWitt JM. Prospective Cross-Sectional Study of the Prevalence of Incidental Pancreatic Cysts During Routine Outpatient Endoscopic Ultrasound. Pancreas. 2015 Oct;44(7):1130-3. doi: 10.1097/MPA.0000000000000408.

    PMID: 26335009BACKGROUND

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Results Point of Contact

Title
John DeWitt, MD, Director, Endoscopic Ultrasound
Organization
Indiana Universtiy Schol of Medicine

Study Officials

  • John M. DeWitt, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscopic Ultrasound

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

September 1, 2009

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

April 20, 2017

Results First Posted

April 20, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Results publication

Locations