Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-31 @ 1:55 AM
Study NCT ID:
NCT00279292
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2006-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of EUS Neurolysis in Pancreas Cancer
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R03DK069947 | NIH | None | https://reporter.nih.gov/quic… | View |