Pancreatic Cancer
Conditions
Keywords
Pancreas, Pancreatic Cancer, Lidocaine, Enzymatic Activity, Cytokines, Chemokines, Gene Expression
Brief summary
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
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.
Interventions
DRUGLidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.
Intervention model description
A prospective randomized placebo-controlled double blinded trial design will be used for the proposed study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria 3. Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease 4. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Independent Ethics Committee (IRB/IEC) 5. Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
Exclusion criteria
1. Has American Society of Anesthesiologists (ASA) physical status \> 3 2. Has hypersensitivity or allergy to amide-linked local anesthetics 3. Has a second or third degree heart block 4. Has severe sinoatrial block 5. Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide 6. Has been treated with amiodarone in the past 7. Has Adams-Stoke syndrome 8. Has Wolff-Parkinson-White syndrome 9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment 10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upregulation or Downregulation of Gene Expression. | Outcomes will be evaluated perioperatively | 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 |
| Specimen outcome measure. | Outcomes will be evaluated perioperatively | Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specimen outcome measure | Perioperatively | CTCs Enumeration |
Countries
United States
Contacts
Primary ContactAlexandra Barabanova, MS
Backup ContactGina E. Votta-Velis, MD PhD
Outcome results
None listed