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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Alcohol Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative imaging indicates possibility of resectable pancreatic cancer Intraoperative biopsy histologically confirming pancreatic adenocarcinoma Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50% Ethanol<br>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<br>* 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<br>* Other names: ethanol celiac plexus neurolysis;|
| Placebo Comparator: Placebo<br>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<br>* 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<br>* Other names: ethanol celiac plexus neurolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is cancer related pain control. |  | Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, periampullary cancer, resectable, unresectable, celiac plexus neurolysis, surgery