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

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: Supportive Care
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

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 ]


Enrollment:	438
Study Start Date:	September 2008
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (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 Name: ethanol celiac plexus neurolysis
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 Name: ethanol celiac plexus neurolysis

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 (Adult, Senior)
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

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

Locations


United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators


Principal Investigator:	Harish Lavu, MD	Thomas Jefferson University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lavu H, Lengel HB, Sell NM, Baiocco JA, Kennedy EP, Yeo TP, Burrell SA, Winter JM, Hegarty S, Leiby BE, Yeo CJ. A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. J Am Coll Surg. 2015 Apr;220(4):497-508. doi: 10.1016/j.jamcollsurg.2014.12.013. Epub 2014 Dec 17.


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:	July 14, 2015
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 Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases	Endocrine System Diseases Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016