Clinical trial NCT00583479: Prospective Study of Celiac Block Injection: 1 vs. 2
Official title: A Prospective Study of Celiac Block Technique: One Injection or Two?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pancreatitis
Pancreatic Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region
timeFrame: 24-hour after the procedure; then every week thereafter until the subject is no longer in the study
Secondary outcomes:
measure: change in medication use
timeFrame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
measure: change is pain score
timeFrame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
measure: complications related to CB
timeFrame: at 24-hours after procedure and every week thereafter until the subject is no longer in the study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian Health: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Julia LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.