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Establishing Standards for Normal Pancreatic EUS

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ClinicalTrials.gov Identifier: NCT02868047
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Timothy Gardner, Dartmouth-Hitchcock Medical Center

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
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.


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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 : September 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.
Criteria

Inclusion Criteria:

  • Undergoing upper EUS for evaluation of the pancreas

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868047


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

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Responsible Party: Timothy Gardner, Associate Profesor, Department of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02868047     History of Changes
Other Study ID Numbers: 21516
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Timothy Gardner, Dartmouth-Hitchcock Medical Center:
chronic pancreatitis
endoscopic ultrasound
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases