Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- the number of circulating tumor cells
研究概览
简要总结
Multiple lines of evidence have shown that perioperative opioids requirement was associated with poor outcomes in cancer patients, including increased cancer progression and metastases and reduced survival in patients with lung, breast, prostate, and bladder cancer. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of perioperative opioids on the number of CTCs in patients receiving robot-assisted laparoscopic radical cystectomy. The difference of the amounts of perioperative opioids is achieved by using general anesthesia combined with intravenous opioid-based analgesia intra- and post-operatively in one group and general analgesia combined with epidural ropivacaine-based analgesia in the other group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age >=18
- •Patients with primary bladder cancer of Stage T2a or higher, who are scheduled for robot-assisted laparoscopic radical cystectomy
- •Written informed consent
排除标准
- •Emergency surgery
- •Palliative surgery
- •Contraindications for epidural anesthesia
- •Metastatic bladder cancer
- •Patients with a history of any other malignancy
- •Chronic opioids medication
- •severe systemic disease (heart, lung, kidney, or immune system)
- •Known hypersensitivity or suspected allergy to intervention drugs
- •Intellectual Disability
结局指标
主要结局
the number of circulating tumor cells
时间窗: on the 3rd day after surgery
The number of circulating tumor cells will be measured by collecting 5ml of venous blood sample.
次要结局
- the number of circulating tumor cells(on the 30 day after surgery)
- Visual Analogue Scale(at 48 hours after surgery)
研究者
Jie Tian
Principal Investigator
RenJi Hospital
