RecruitingInterventionalEarly Phase 1

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

NCT ID: NCT04048278Sponsor: University of Illinois at ChicagoLast updated: 2026-06-15

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.

Arms & interventions

DrugLidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
DrugSaline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Outcome measures

Primary

Specimen outcome measure.
Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.
Time frame: Outcomes will be evaluated perioperatively
Specimen outcome measure.
Cytokine Levels in Serum (pg/ml)
Time frame: Outcomes will be evaluated perioperatively
Specimen outcome measure.
Chemokine levels in serum (pg/ml)
Time frame: 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
Time frame: Outcomes will be evaluated perioperatively

Secondary

Specimen outcome measure
Time frame: Perioperatively

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

University of Illnois at Chicago

Chicago, Illinois, 60612

Recruiting

Gina E Votta-Velis, MD PhD · Contact

(312)996-4020 ginavot@uic.edu

Alexandra Barabanova, MS · Contact

(312)355-5733 barabano@uic.edu

E. Gina Votta-Velis, MD PhD · Principal Investigator

Ajay Rana, PhD · Sub Investigator

Pier C. Giulianotti, MD · Sub Investigator

Alain A. Borgeat, MD · Sub Investigator

Sandeep Kumar, PhD · Sub Investigator

Antonio Gangemi, MD · Sub Investigator

Valentina Valle, MD · Sub Investigator

References

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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.(PubMed)
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.(PubMed)