Randomized Trial of EUS Neurolysis in Pancreas Cancer
This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain|
- To evaluate the efficacy of treatment of ethanol injection versus placebo
- injection for pain in pancreatic cancer patients at 1 month and 3 months.
- To evaluate mortality and surgical morbidity at 1 month and 3 months
- To evaluate magnitude of narcotic use after treatment at 1 month and 3 months
- To estimate the period of time pain scores will remain below baseline levels
- To estimate the effect of treatment on quality of life at 1 month and 3 month
|Study Start Date:||August 2004|
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.
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Michael B Wallace, MD MPH||Mayo Clinic|