Establishing Standards for Normal Pancreatic EUS

Chronic Pancreatitis Clinical Trial

Official title:

Establishing Standards for Normal Pancreatic EUS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868047
• Other study ID #: 21516
• Status: Completed
• Phase: N/A
• First received: January 2, 2014
• Last updated: August 13, 2016
• Start date: September 2010
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Dartmouth Committee for the Protection of Human Subjects
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Procedure:
• Endoscopic Ultrasound
Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Hyperechoic Strands		Day 1	No
Primary	Number of Patients with Hyperechoic Foci		Day 1	No
Primary	Number of Patients with Lobular Contour		Day 1	No
Primary	Number of Patients with Cysts		Day 1	No
Primary	Number of Patients with Duct Irregularity		Day 1	No
Primary	Number of Patients with Ductal Calculi		Day 1	No
Primary	Number of Patients with Hyperechoic Duct Wall		Day 1	No
Primary	Number of Patients with Dilated Dilated Side Branches		Day 1	No
Primary	Number of Patients with Dilated Pancreatic Duct		Day 1	No