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Sponsored by: |
Thomas Jefferson University |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00806611 |
Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Procedure: Alcohol Block |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer |
Estimated Enrollment: | 290 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
50% Ethanol: Experimental
Operating surgeon injects 20 ml of 50% ethanol on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
|
Procedure: Alcohol Block
Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
|
Placebo: Placebo Comparator
Operating surgeon injects 20 ml of saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
|
Procedure: Alcohol Block
Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
|
Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.
This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Eugene P Kennedy, M.D. | 215-305-9402 | Eugene.Kennedy@jefferson.edu |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Eugene P. Kennedy, M.D. 215-305-9402 Eugene.Kennedy@jefferson.edu | |
Contact: Maureen O'Connell, B.S.N. 215-955-1661 Maureen.OConnell@jefferson.edu |
Principal Investigator: | Eugene P. Kennedy, M.D. | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University ( Eugene P. Kennedy, M.D. ) |
Study ID Numbers: | CCRRC 2007-32, 08D.380 |
Study First Received: | December 10, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00806611 |
Health Authority: | United States: Institutional Review Board |
pancreatic cancer periampullary cancer resectable |
unresectable celiac plexus neurolysis surgery |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Celiac Disease Endocrinopathy Ethanol Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |