跳至主要内容
临床试验/NCT04358718
NCT04358718已完成不适用

Influence of Peri-operative Opioids on Circulating Tumor Cells in Patients Undergoing Robot-Assisted Laparoscopic Radical Cystectomy

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年6月2日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie Tian

Principal Investigator

RenJi Hospital

研究点 (1)

Loading locations...

相似试验