This a randomized, double-blind, sham-controlled trial to determine the effectiveness of celiac plexus neurolysis (CRN) as an adjunct to standard medical therapy for pain control in patients with unresectable pancreatic cancer and moderate to severe pain. Nearly 100% of patients with pancreatic cancer experience pain. Despite the availability of narcotic analgesics, up to 50% of patients have poorly controlled pain. A 1993 randomized placebo-controlled trial of surgical CRN, performed at the time of exploratory laparotomy, demonstrated CRN to be safe and effective. Recent advances in imaging methods (CT, MRI, EUS) have allowed better pre-operative identification of patients with unresectable disease, such that patients rarely require exploratory laparotomy. For this reason a minimally invasive method of pain control in pancreatic cancer which could be performed in conjunction with staging and tissue confirmation, would be a major clinical advance. Endoscopic ultrasound is a widely used, minimally invasive, highly accurate and safe method of staging, and tissue biopsy of pancreatic cancer. Phase II, uncontrolled trials suggest that EUS is also capable of delivering effective celiac plexus neurolysis (EUS-CPN). To date, there are no published controlled trials or EUS-CPN. This study will enroll patients who are undergoing diagnostic EUS-FNA procedures for staging of pancreatic cancer. Those found to be unresectable would be randomized """"""""intra-op"""""""" to either sham or real EUS-CPN. Outcomes will include pain scores, quality of life, narcotic use and survival. The primary outcome will be a reduction in pain at 1 month. Secondary outcomes will include the durability of pain control, quality of life, narcotic use and narcotic side effects. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Research Grants (R03)
Project #
1R03DK069947-01A1
Application #
6969073
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (M2))
Program Officer
Robuck, Patricia R
Project Start
2005-08-20
Project End
2007-07-31
Budget Start
2005-08-20
Budget End
2006-07-31
Support Year
1
Fiscal Year
2005
Total Cost
$141,448
Indirect Cost
Name
Mayo Clinic Jacksonville
Department
Type
DUNS #
153223151
City
Jacksonville
State
FL
Country
United States
Zip Code
32224