Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer - Full Text View

Sponsor:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00806611

Purpose

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:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Celiac Disease Pancreatic Cancer Surgery

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

The primary endpoint is cancer related pain control. [ Time Frame: Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Preoperative imaging indicates possibility of resectable pancreatic cancer
Intraoperative biopsy histologically confirming pancreatic adenocarcinoma

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806611

Contacts

Contact: Eugene P Kennedy, M.D.

215-305-9402

Eugene.Kennedy@jefferson.edu

Locations

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

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Eugene P. Kennedy, M.D.

Thomas Jefferson University

More Information

No publications provided

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:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00806611 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

pancreatic cancer
periampullary cancer
resectable

unresectable
celiac plexus neurolysis
surgery

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on March 18, 2010