$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Prospective Study of Celiac Block Injection: 1 vs. 2

2002-06

2008-07

2008-07

100

Study Overview

Prospective Study of Celiac Block Injection: 1 vs. 2

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.

N/A

  • Chronic Pancreatitis
  • Pancreatic Cancer
  • OTHER: one injection into the celiac ganglion
  • OTHER: two injections into the celiac ganglion
  • 0203-32

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 Registration Dates Results Reporting Dates Study Record Updates

2007-12-20  

N/A  

2012-09-11  

2007-12-20  

N/A  

2012-09-12  

2007-12-31  

N/A  

2012-09  

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region24-hour after the procedure; then every week thereafter until the subject is no longer in the study
Secondary Outcome MeasuresMeasure DescriptionTime Frame
change in medication useat 24-hours after procedure and every week thereafter until the subject is no longer in the study
change is pain scoreat 24-hours after procedure and every week thereafter until the subject is no longer in the study
complications related to CBat 24-hours after procedure and every week thereafter until the subject is no longer in the study

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: Julia LeBlanc, MD, MPH, Indiana University

    Publications

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

    General Publications

    • LeBlanc JK, Al-Haddad M, McHenry L, Sherman S, Juan M, McGreevy K, Johnson C, Howard TJ, Lillemoe KD, DeWitt J. A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two? Gastrointest Endosc. 2011 Dec;74(6):1300-7. doi: 10.1016/j.gie.2011.07.073. Epub 2011 Oct 13.
    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate