Establishing Standards for Normal Pancreatic EUS

Study Overview
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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.

Official Title
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Establishing Standards for Normal Pancreatic EUS

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Procedure: Endoscopic Ultrasound


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Hyperechoic Strands |  | Day 1 | 
| Number of Patients with Hyperechoic Foci |  | 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 Ductal Calculi |  | Day 1 | 
| Number of Patients with Hyperechoic Duct Wall |  | Day 1 | 
| Number of Patients with Dilated Dilated Side Branches |  | Day 1 | 
| Number of Patients with Dilated Pancreatic Duct |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pancreatitis, endoscopic ultrasound