Establishing Standards for Normal Pancreatic EUS

NCT ID: NCT02868047

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pancreatitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected Chronic Pancreatitis

Included patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis

Endoscopic Ultrasound

Intervention Type PROCEDURE

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.

Endoscopic Ultrasound

Intervention Type PROCEDURE

Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis

Interventions

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Endoscopic Ultrasound

Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria

* pregnancy
* age less than 18
* inability to provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Timothy Gardner

Associate Profesor, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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21516

Identifier Type: -

Identifier Source: org_study_id

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