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Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01442454
Recruitment Status : Terminated (The PI left and then the PI who would be taking over has left. No other investigator wanted to take the study since not sponsored)
First Posted : September 28, 2011
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.

Condition or disease Intervention/treatment
Chronic Pancreatitis Other: chronic pancreatitis

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis: A Prospective Correlation With Intraoperative Findings and Surgical Pathology
Study Start Date : October 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Chronic Pancreatitis Other: chronic pancreatitis
No intervention, subjects followed through surgery


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing EUS
Criteria

Patients who are eligible are individuals who have:

  • normal pancreas
  • suspected chronic pancreatitis
  • established chronic pancreatitis (by ERCP, MRI, previous EUS, CT)
  • pancreatic cancer

Patients who are not eligible are individuals who have:

• an uncorrectable coagulopathy (platelet <50,000, INR>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01442454


Locations
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01442454     History of Changes
Other Study ID Numbers: 1008-15
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Indiana University:
chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases