Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

Study Overview
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Brief Summary
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This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.

Detailed Description
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Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer. Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.

Official Title
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A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies

Conditions
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Pancreas Cancer, Biliary Tract Cancer

Intervention / Treatment
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* Other: Alcohol Injection
* Other: Placebo Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer. Physiologic suitability for major abdominal surgery Aged 18 years and older Written informed consent Ability to understand and comply with study guidelines. Exclusion Criteria: Pregnancy Previous, preoperative celiac nerve block Neoadjuvant chemotherapy or radiation therapy Incomplete tumor resection (R2 resection, grossly positive resection margin) Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings Known metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol Injection<br>Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis | Other: Alcohol Injection<br>* Celiac plexus neurolysis by alcohol injection<br>* Other names: Ethanol Injection;|
| Placebo Comparator: Placebo Injection<br>Celiac plexus injection - placebo injection | Other: Placebo Injection<br> <br> * Other names: Normal saline injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Control |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific, recurrence-free survival |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Pain