Lidocaine Infusion in Pancreatic Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Specimen outcome measure. [Срок оценки: Outcomes will be evaluated perioperatively]
• Specimen outcome measure. [Срок оценки: Outcomes will be evaluated perioperatively]
• Specimen outcome measure. [Срок оценки: Outcomes will be evaluated perioperatively]
• Upregulation or Downregulation of Gene Expression. [Срок оценки: Outcomes will be evaluated perioperatively]

Вторичные конечные точки (1)

• Specimen outcome measure [Срок оценки: Perioperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Illnois at Chicago — Chicago

Публикации

• 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. doi: 10.1245/aso.2003.02.007. PMID 14527919
• Mokbel K, Choy C, Engledow A. The effect of surgical wounding on tumour development. Eur J Surg Oncol. 2000 Mar;26(2):195. doi: 10.1053/ejso.1999.0771. No abstract available. PMID 10744945
• 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. PMID 30640648
• 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. PMID 24218336

Идентификаторы

NCT: NCT04048278 · 2017-1365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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