NCT00279292

Randomized Trial of EUS Neurolysis in Pancreas Cancer

Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Celiac Plexus Neurolysis

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2006-01-19
• Last updated: 2015-10-14

Locations

2 sites across 1 country: United States