Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer
This study is currently recruiting participants.
Verified May 2013 by Thomas Jefferson University
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00806611
First received: December 10, 2008
Last updated: May 6, 2013
Last verified: May 2013
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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 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 Names:
|
|
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:
|
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: 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 6, 2013 |
| 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 May 23, 2013