Status:
COMPLETED
Randomized Trial of EUS Neurolysis in Pancreas Cancer
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 underuti...
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 pai...
Eligibility Criteria
Inclusion
- 1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information.
- 2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.
- 3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy.
- 4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation \>90%.
- 5 \> 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances.
- 8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.
- 9 Life expectancy \> 3 months 3.10 Signed and dated informed consent.
Exclusion
- Unable to sign informed consent
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00279292
Start Date
August 1 2004
End Date
January 1 2007
Last Update
October 14 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224