NCT01442454

Brief Summary

The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

September 26, 2011

Last Update Submit

February 29, 2016

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis

Study Arms (1)

Chronic Pancreatitis

Other: chronic pancreatitis

Interventions

chronic pancreatitisOTHER

No intervention, subjects followed through surgery

Chronic Pancreatitis

Eligibility Criteria

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

Patients undergoing EUS

Patients who are eligible are individuals who have: * normal pancreas * suspected chronic pancreatitis * established chronic pancreatitis (by ERCP, MRI, previous EUS, CT) * pancreatic cancer Patients who are not eligible are individuals who have: • an uncorrectable coagulopathy (platelet \<50,000, INR\>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 28, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

US(1)