Lidocaine Infusion in Pancreatic Cancer

Study Overview
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Brief Summary
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This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer. A prospective randomized controlled double blinded trial design will be used for the proposed study.

Detailed Description
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The primary objective of this study is to determine the effect of IV lidocaine infusion on various enzymatic activities and associated pathways in isolated CTCs as well as the number of CTCs during the perioperative period in patients undergoing robotic pancreatectomy for pancreatic cancer. It is expected that by downregulating the pathways by lidocaine might affect the enzymatic activity in those CTCs as well as the number of CTCs in the circulation. A prospective randomized controlled double blinded trial design will be used for the proposed study. Patients undergoing robotic pancreatectomy for pancreatic cancer will be randomized (ratio 1:1) into two groups: one group will receive a 24-h normal saline infusion and the second group will receive a 24-h lidocaine infusion. Blood samples will be collected in different times perioperatively in order to evaluate the objectives of the study.

Official Title
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Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride
* Drug: Saline Solution for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is considered resectable as well as other types of pancreatic cancer (malignant endocrine and exocrine tumors) Has measurable disease, defined as at least 1 tumor that fulfills the criteria Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC) Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy. Exclusion Criteria: Has American Society of Anesthesiologists (ASA) physical status > 3 Has hypersensitivity or allergy to amide-linked local anesthetics Has a second or third degree heart block Has severe sinoatrial block Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide Has been treated with amiodarone in the past Has Adams-Stoke syndrome Has Wolff-Parkinson-White syndrome Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Hydrochloride<br>The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h | Drug: Lidocaine Hydrochloride<br>* IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control<br>* Other names: Xylocaine;|
| Placebo Comparator: Saline Solution for Injection<br>The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr) | Drug: Saline Solution for Injection<br>* IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen outcome measure. | Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells. | Outcomes will be evaluated perioperatively | 
| Specimen outcome measure. | Cytokine Levels in Serum (pg/ml) | Outcomes will be evaluated perioperatively | 
| Specimen outcome measure. | Chemokine levels in serum (pg/ml) | Outcomes will be evaluated perioperatively | 
| Upregulation or Downregulation of Gene Expression. | Upregulation or downregulation of gene expression will be measured with the Real Time (RT) square Profiler Polimerase Chain Reaction (PCR )Array Analysis, and Real Time PCR | Outcomes will be evaluated perioperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen outcome measure | CTCs Enumeration | Perioperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression