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Lidocaine Infusion in Pancreatic Cancer

NCT04048278 · University of Illinois at Chicago
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Official title
Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 46 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2018-11-08
Estimated completion: 2026-01-01
Last updated: 2025-03-03
Interventions
Drug: Lidocaine HydrochlorideDrug: Saline Solution for Injection
Primary outcomes
  • Specimen outcome measure. (Outcomes will be evaluated perioperatively)
  • Specimen outcome measure. (Outcomes will be evaluated perioperatively)
  • Specimen outcome measure. (Outcomes will be evaluated perioperatively)
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactAlexandra Barabanova, MS · contact · barabano@uic.edu · (312)996-4020
ContactGina E. Votta-Velis, MD PhD · contact · barabano@uic.edu · (312)996-4020
InvestigatorGina E. Votta-Velis, MD PhD · principal_investigator, Associate Professor
All locations (1)
University of Illnois at ChicagoRecruiting
Chicago, Illinois, United States
Lidocaine Infusion in Pancreatic Cancer · TrialPath