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A Prospective Study of EUS Guided Celiac Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00583271
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Indiana University

Brief Summary:
The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.

Condition or disease Intervention/treatment
Chronic Pancreatitis Pancreatic Cancer Drug: triamcinolone Drug: 98% dehydrated alcohol

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Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness
Study Start Date : June 2002
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Group/Cohort Intervention/treatment
1
subjects who are getting a celiac block for chronic pancreatitis
Drug: triamcinolone
80mg of triamcinolone injected into the celiac ganglion during the EUS-CB
Other Name: Kenalog 80mg

2
subjects who are getting a celiac block for pancreatic cancer
Drug: 98% dehydrated alcohol
10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block.
Criteria

Inclusion Criteria:

  • Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study.
  • Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS.
  • No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
  • Patient must provide signed written informed consent

Exclusion Criteria:

  • Patients that have had a previous celiac plexus block are eligible for this study

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): NCT00583271


Locations
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United States, Indiana
Clarian Health: Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Julia LeBlanc, MD, MPH Indiana University
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Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00583271    
Other Study ID Numbers: 0205-04B
IRB #0205-04B
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Pancreatic Diseases
Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs