Prospective Study of Celiac Block Injection: 1 vs. 2
Completed · Phase 4
Conditions studied: Chronic Pancreatitis, Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT00583479
- Run by
- Indiana University
- People needed
- 100
- Starts
- 2002-06-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2012-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Clarian Health: Indiana University Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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