RECRUITING

Lidocaine Infusion in Pancreatic Cancer

Conditions

Pancreatic Cancer Pancreas Lidocaine Enzymatic Activity Cytokines Chemokines Gene Expression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-11-08

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04048278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Alexandra Barabanova, MS

CONTACT

(312)996-4020

barabano@uic.edu

Gina E. Votta-Velis, MD PhD

CONTACT

(312)996-4020

barabano@uic.edu

Principal Investigator

Gina E. Votta-Velis, MD PhD

PRINCIPAL_INVESTIGATOR

Associate Professor

Study Locations (Sites)

University of Illnois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Gina E. Votta-Velis, MD PhD, PRINCIPAL_INVESTIGATOR, Associate Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-08

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2018-11-08

Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

Pancreas
Pancreatic Cancer
Lidocaine
Enzymatic Activity
Cytokines
Chemokines
Gene Expression

Additional Relevant MeSH Terms

Pancreatic Cancer