Prospective Study of Celiac Block Injection: 1 vs. 2 - Full Text View

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 IV

MedlinePlus related topics:

Cancer Celiac Disease Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study

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

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

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

Responsible Party:	Indiana University ( Dr. Julia LeBlanc, MD, MPH )
Study ID Numbers:	0203-32
First Received:	December 20, 2007
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00583479
Health Authority:	United States: Institutional Review Board