Prospective Study of Celiac Block Injection: 1 vs. 2

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00583479
First received: December 20, 2007
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Pancreatitis
Pancreatic Cancer
Other: one injection into the celiac ganglion
Other: two injections into the celiac ganglion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Study of Celiac Block Technique: One Injection or Two?

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in medication use [ Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study ] [ Designated as safety issue: No ]
  • change is pain score [ Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study ] [ Designated as safety issue: No ]
  • complications related to CB [ Time Frame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: June 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583479

Locations
United States, Indiana
Clarian Health: Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Julia LeBlanc, MD, MPH Indiana University
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Julia LeBlanc, MD, MPH, Indiana University
ClinicalTrials.gov Identifier: NCT00583479     History of Changes
Other Study ID Numbers: 0203-32
Study First Received: December 20, 2007
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014