Establishing Standards for Normal Pancreatic EUS

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Procedure: Endoscopic Ultrasound

• Registration Number: NCT02868047
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2014-01-02
• Primary Completion: 2014-09
• Study Completion: 2015-05
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-13
• Last Update Submitted: 2016-08-13
• Study First Posted: 2016-08-16
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Chronic Pancreatitis	Endoscopic Ultrasound	Included patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis
NOT Suspected Chronic Pancreatitis	Endoscopic Ultrasound	Included patients will be those scheduled for an upper endoscopic ultrasound examination without suspected chronic pancreatitis.

Primary Outcome Measures

Name	Time	Method
Number of Patients with Hyperechoic Foci	Day 1
Number of Patients with Dilated Dilated Side Branches	Day 1
Number of Patients with Ductal Calculi	Day 1
Number of Patients with Lobular Contour	Day 1
Number of Patients with Cysts	Day 1
Number of Patients with Duct Irregularity	Day 1
Number of Patients with Hyperechoic Duct Wall	Day 1
Number of Patients with Dilated Pancreatic Duct	Day 1
Number of Patients with Hyperechoic Strands	Day 1

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States