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OpenTrials
Completed

NCT Number: NCT02868047

Establishing Standards for Normal Pancreatic EUS

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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing upper EUS for evaluation of the pancreas

Exclusion criteria

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

Treatment and study plan

Endoscopic Ultrasound

Procedure

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

Primary outcomes

  1. Number of Patients with Hyperechoic Strands

    Time frame: Day 1

  2. Number of Patients with Hyperechoic Foci

    Time frame: Day 1

  3. Number of Patients with Lobular Contour

    Time frame: Day 1

  4. Number of Patients with Cysts

    Time frame: Day 1

  5. Number of Patients with Duct Irregularity

    Time frame: Day 1

  6. Number of Patients with Ductal Calculi

    Time frame: Day 1

  7. Number of Patients with Hyperechoic Duct Wall

    Time frame: Day 1

  8. Number of Patients with Dilated Dilated Side Branches

    Time frame: Day 1

  9. Number of Patients with Dilated Pancreatic Duct

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Aug 16, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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