Establishing Standards for Normal Pancreatic EUS

August 13, 2016 updated by: Timothy Gardner, Dartmouth-Hitchcock Medical Center
There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic pancreatitis is a very challenging disease to diagnose as their is no gold standard for diagnosis. Increasingly, endoscopic ultrasound (EUS) has been used as a means of diagnosing chronic pancreatitis. However, there are questions about whether intra-rater reliability and/or validity are high enough to warrant using EUS to make the diagnosis of chronic pancreatitis.

The purpose of this observational study is to determine the degree of correlation between two expert endosonographers in evaluating minimal standard criteria (MST) in the same patient during the same EUS exam. Patients both with and without chronic pancreatitis will be included in the study to try and determine the validity and reliability of back-to-back EUS examinations.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.

Description

Inclusion Criteria:

  • Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria:

  • pregnancy
  • age less than 18
  • inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected Chronic Pancreatitis
Included patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis
Procedure: Endoscopic Ultrasound
Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis
NOT Suspected Chronic Pancreatitis
Included patients will be those scheduled for an upper endoscopic ultrasound examination without suspected chronic pancreatitis.
Procedure: Endoscopic Ultrasound
Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Hyperechoic Strands
Time Frame: Day 1
Day 1
Number of Patients with Hyperechoic Foci
Time Frame: Day 1
Day 1
Number of Patients with Lobular Contour
Time Frame: Day 1
Day 1
Number of Patients with Cysts
Time Frame: Day 1
Day 1
Number of Patients with Duct Irregularity
Time Frame: Day 1
Day 1
Number of Patients with Ductal Calculi
Time Frame: Day 1
Day 1
Number of Patients with Hyperechoic Duct Wall
Time Frame: Day 1
Day 1
Number of Patients with Dilated Dilated Side Branches
Time Frame: Day 1
Day 1
Number of Patients with Dilated Pancreatic Duct
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

August 13, 2016

First Posted (ESTIMATE)

August 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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