Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model and Human Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Upregulation or Downregulation of Gene Expression.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Both patients and the physicians performing the cases will be unaware of who receives lidocaine or placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Lidocaine Hydrochloride (Drug)
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)
干预措施: Saline Solution for Injection (Drug)
结局指标
主要结局
Upregulation or Downregulation of Gene Expression.
时间窗: 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
Specimen outcome measure.
时间窗: Outcomes will be evaluated perioperatively
Chemokine levels in serum (pg/ml)
次要结局
- Specimen outcome measure(Perioperatively)
研究者
Effrossyni Votta-Velis
Associate Professor
University of Illinois at Chicago