Lidocaine Infusion in Pancreatic Cancer

Last updated: February 26, 2025
Sponsor: University of Illinois at Chicago
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Pancreatitis

Pancreatic Disorders

Treatment

Lidocaine Hydrochloride

Saline Solution for Injection

Clinical Study ID

NCT04048278
2017-1365
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that isconsidered resectable as well as other types of pancreatic cancer (malignantendocrine 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 surgicalexploration found to have metastatic disease

  4. Has read, understood and signed the informed consent form (ICF) approved by theIndependent Review Board/Independent Ethics Committee (IRB/IEC)

  5. Prior systemic treatments for metastatic disease are permitted, including targetedtherapies, biologic response modifiers, chemotherapy, hormonal therapy, orinvestigational therapy.

Exclusion

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 unlesscontrolled by anticoagulant treatment

  10. Has a known history of human immunodeficiency virus (HIV) positivity or untreatedand uncontrolled hepatitis B or C

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Lidocaine Hydrochloride
Phase: 1
Study Start date:
November 08, 2018
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • University of Illnois at Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

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