Resectable Pancreatic Adenocarcinoma - Does the Type of Anesthesia Have an Impact on Circulating Tumor Cells?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Peak of CTC in the postoperative phase after curative tumor removal
研究概览
简要总结
Proportion of circulating tumor cells (CTC) in the postoperative phase after curative tumor removal of pancreatic cancer will be determined and correlated to the accordance of anesthesia (desflurane versus propofol)
详细描述
This prospective, randomized study will be conducted over a 36-month period to investigate whether commonly used anesthetics (volatile versus intravenous) have an effect on the changes or occurrence of CTC in patients suffering from primary pancreatic cancer undergoing curative surgery. The specific research question is if there are changes of the CTC count in the postoperative phase in the desflurane group (intervention) compared to the propofol one (control). A secondary question is if these changes can be correlated to tumor outcome.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85
- •ASA I-III ( American Society of Anesthesiologists)
- •Resectable pancreatic adenocarcinoma
- •Primary surgery
- •No neoadjuvant therapy
- •Written informed consent
排除标准
- •Metastatic disease
- •Other than primary surgery (recurrence, reconstruction)
- •Pre-operative chemotherapy
- •Chronic opioid use
- •Known hypersensitivity or suspected allergy to propofol, soya or egg proteins
- •Known hypersensitivity to volatile anaesthetics (malignant hyperthermia)
- •Pregnancy
- •Breast feeding
- •Enrolment in any other clinical trial during the course of this trial, 30 days prior to its beginning or 30 days after its completion
研究组 & 干预措施
Desflurane
General anesthesia with Desflurane
干预措施: Desflurane (Drug)
结局指标
主要结局
Peak of CTC in the postoperative phase after curative tumor removal
时间窗: Day 0 to Day 7
CTC will be counted and peak of CTC will be determined.
次要结局
- Month to Tumor recurrence(1 year)
- Kinetics of CTC after surgery up to day 7(1 year)
- Number of surviving patients(1 year)