Lidocaine Infusion in Pancreatic Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lidocaine Hydrochloride The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h |
Drug: Lidocaine Hydrochloride
IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
|
| Placebo Comparator: Saline Solution for Injection The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr) |
Drug: Saline Solution for Injection
IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Specimen outcome measure. [Outcomes will be evaluated perioperatively]
Src Tyrosine Kinase Enzymatic activity in CTCs. Fluorescence intensity will be used to measure Src phosphorylation in circulating tumor cells.
- Specimen outcome measure. [Outcomes will be evaluated perioperatively]
Cytokine Levels in Serum (pg/ml)
- Specimen outcome measure. [Outcomes will be evaluated perioperatively]
Chemokine levels in serum (pg/ml)
- Upregulation or Downregulation of Gene Expression. [Outcomes will be evaluated perioperatively]
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
Secondary Outcome Measures
- Specimen outcome measure [Perioperatively]
CTCs Enumeration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
-
Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
Exclusion Criteria:
-
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
-
Is currently being treated with any of the following class I antiarrhythmic drugs; quinidine, flecainide, disopyramide, or procainamide
-
Has been treated with amiodarone in the past
-
Has Adams-Stoke syndrome
-
Has Wolff-Parkinson-White syndrome
-
Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment
-
Has a known history of human immunodeficiency virus (HIV) positivity or untreated and uncontrolled hepatitis B or C
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illnois at Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
Investigators
- Principal Investigator: Gina E. Votta-Velis, MD PhD, Associate Professor
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195.
- Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. Review.
- 2017-1365