Skip to content

Establishing Standards for Normal Pancreatic EUS

Establishing Standards for Normal Pancreatic EUS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02868047
Enrollment
54
Registered
2016-08-16
Start date
2010-09-30
Completion date
2015-05-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis, endoscopic ultrasound

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.

Interventions

PROCEDUREEndoscopic Ultrasound

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

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frame
Number of Patients with Hyperechoic StrandsDay 1
Number of Patients with Hyperechoic FociDay 1
Number of Patients with Lobular ContourDay 1
Number of Patients with CystsDay 1
Number of Patients with Duct IrregularityDay 1
Number of Patients with Ductal CalculiDay 1
Number of Patients with Hyperechoic Duct WallDay 1
Number of Patients with Dilated Dilated Side BranchesDay 1
Number of Patients with Dilated Pancreatic DuctDay 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026