Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2014 by Thomas Jefferson University

Sponsor:

Information provided by (Responsible Party):

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT00806611

First received: December 10, 2008

Last updated: November 10, 2014

Last verified: November 2014

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Cancer Celiac Disease Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

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 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 50% Ethanol 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 Other Names: ethanol celiac plexus neurolysis alcohol block
Placebo Comparator: Placebo 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 Other Names: ethanol celiac plexus neurolysis alcohol block

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Harish Lavu, MD	215-305-9402	Harish.Lavu@jefferson.edu
Contact: Sharon Molotsky, RN, BSN

Locations


United States, Pennsylvania
Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Harish Lavu, MD 215-955-9402
Contact: Sharon Molotsky, RN, BSN 215-955-9402
Sub-Investigator: Charles Yeo, MD
Sub-Investigator: Ernest Rosato, MD
Sub-Investigator: Karen Chojnacki, MD
Sub-Investigator: Adam Berger, MD
Sub-Investigator: Jordan Winter, MD
Sub-Investigator: Leonidas Koniaris, MD
Sub-Investigator: Patricia Sauter, MSN, CRNP
Sub-Investigator: Benjamin Leiby, PhD, MPH
Sub-Investigator: Sherry Burrell, RN, MSN

Sponsors and Collaborators

Thomas Jefferson University

Investigators


Principal Investigator:	Harish Lavu, MD	Thomas Jefferson University

More Information

No publications provided


Responsible Party:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00806611 History of Changes
Other Study ID Numbers:	08D.380, 2007-32
Study First Received:	December 10, 2008
Last Updated:	November 10, 2014
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:


Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms	Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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