A Prospective Study of EUS Guided Celiac Block

September 3, 2014 updated by: Indiana University

A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clarian Health: Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Julia LeBlanc, MD, MPH, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 3, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0205-04B
  • IRB #0205-04B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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