Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain
This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided
celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have
significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic
ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same
medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine
and ethanol. Patients will be followed for at least 3 months for pain, quality of life and
narcotic usage.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To evaluate the efficacy of treatment of ethanol injection versus placebo
Michael B Wallace, MD MPH
Principal Investigator
Mayo Clinic
United States: Federal Government
R03 DK69947 (completed)
NCT00279292
August 2004
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |