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Lidocaine Infusion in Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine Hydrochloride

    Drug

    IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

  • Saline Solution for Injection

    Drug

    IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Lidocaine HydrochlorideExperimental treatment 1 intervention
Group B: Saline Solution for InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Specimen outcome measure.

Cytokine Levels in Serum (pg/ml)

Time frame
Outcomes will be evaluated perioperatively
3

Specimen outcome measure.

Chemokine levels in serum (pg/ml)

Time frame
Outcomes will be evaluated perioperatively
4

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 outcomes

1

Specimen outcome measure

CTCs Enumeration

Time frame
Perioperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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