- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048278
Lidocaine Infusion in Pancreatic Cancer
Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Alexandra Barabanova, MS
- Phone Number: (312)996-4020
- Email: barabano@uic.edu
Study Contact Backup
- Name: Gina E. Votta-Velis, MD PhD
- Phone Number: (312)996-4020
- Email: barabano@uic.edu
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illnois at Chicago
-
Contact:
- Gina E Votta-Velis, MD PhD
- Phone Number: 312-996-4020
- Email: ginavot@uic.edu
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Principal Investigator:
- E. Gina Votta-Velis, MD PhD
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Sub-Investigator:
- Ajay Rana, PhD
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Sub-Investigator:
- Pier C. Giulianotti, MD
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Sub-Investigator:
- Alain A. Borgeat, MD
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Sub-Investigator:
- Sandeep Kumar, PhD
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Sub-Investigator:
- Antonio Gangemi, MD
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Sub-Investigator:
- Valentina Valle, MD
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Contact:
- Alexandra Barabanova, MS
- Phone Number: (312)355-5733
- Email: barabano@uic.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine Hydrochloride
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
|
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
|
Placebo Comparator: Saline Solution for Injection
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)
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IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specimen outcome measure.
Time Frame: 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.
|
Outcomes will be evaluated perioperatively
|
Specimen outcome measure.
Time Frame: Outcomes will be evaluated perioperatively
|
Cytokine Levels in Serum (pg/ml)
|
Outcomes will be evaluated perioperatively
|
Specimen outcome measure.
Time Frame: Outcomes will be evaluated perioperatively
|
Chemokine levels in serum (pg/ml)
|
Outcomes will be evaluated perioperatively
|
Upregulation or Downregulation of Gene Expression.
Time Frame: 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
|
Outcomes will be evaluated perioperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specimen outcome measure
Time Frame: Perioperatively
|
CTCs Enumeration
|
Perioperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gina E. Votta-Velis, MD PhD, Associate Professor
Publications and helpful links
General Publications
- Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.
- Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001.
- Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available.
- Han L, Chen W, Zhao Q. Prognostic value of circulating tumor cells in patients with pancreatic cancer: a meta-analysis. Tumour Biol. 2014 Mar;35(3):2473-80. doi: 10.1007/s13277-013-1327-5. Epub 2013 Nov 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 2017-1365
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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