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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 8, 2014
Last verified: May 2014
  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:


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: May 8, 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 Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014