Establishing Standards for Normal Pancreatic EUS

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02868047

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Procedure: Endoscopic Ultrasound

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 Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Establishing Standards for Normal Pancreatic EUS

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria:

pregnancy
age less than 18
inability to provide written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy Gardner, Associate Profesor, Department of Medicine, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT02868047

Other Study ID Numbers:

21516

First Posted:

Aug 16, 2016

Last Update Posted:

Aug 16, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Timothy Gardner, Associate Profesor, Department of Medicine, Dartmouth-Hitchcock Medical Center

chronic pancreatitis

endoscopic ultrasound

Additional relevant MeSH terms:

Pancreatitis

Pancreatitis, Chronic

Study Results

No Results Posted as of Aug 16, 2016