Prospective Study of Celiac Block Injection: 1 vs. 2

September 11, 2012 updated by: Indiana University

A Prospective Study of Celiac Block Technique: One Injection or Two?

The purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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

Description

Inclusion Criteria:

  • Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for EUS-guided celiac block will be eligible to participate in this study. Chronic pancreatitis and pancreatic cancer must be measured and documented by prior CT, ERCP, or EUS.
  • Patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit survivability of the sedation given or the procedure.
  • Age > or = to 18 years
  • No evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc)
  • No evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc)
  • 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.
  • Patients that have had a previous celiac plexus block are eligible for this study

Exclusion Criteria:

  • The patient's celiac trunk should be imaged clearly under endoscopic ultrasound. The patient's celiac plexus should be accessed easily with a needle for the medication injection. If this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
subjects who get one medication injection into the celiac ganglion during the EUS
Other: one injection into the celiac ganglion
one injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer
Other: B
subjects who get divided dose of the medication injected into two locations within the celiac ganglion during the EUS
Other: two injections into the celiac ganglion
two injection into the celiac ganglion of the standard medication for CB for with chronic pancreatitis or pancreatic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
Time Frame: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study
24-hour after the procedure; then every week thereafter until the subject is no longer in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
change in medication use
Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
at 24-hours after procedure and every week thereafter until the subject is no longer in the study
change is pain score
Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
at 24-hours after procedure and every week thereafter until the subject is no longer in the study
complications related to CB
Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
at 24-hours after procedure and every week thereafter until the subject is no longer in the study

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2008

Study Completion (Actual)

July 1, 2008

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 12, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0203-32

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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