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临床试验/NCT05109130
NCT05109130进行中(未招募)不适用

Sixth Affiliated Hospital, Sun Yat-sen University

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery

研究概览

简要总结

The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.

详细描述

Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Mid-low rectal cancer.
  • Single lesion.
  • No metastasis.
  • Clinical Stage T2-3, N0-1.

排除标准

  • History of malignant tumors.
  • Acute bowel obstruction, bleeding or perforation.
  • Received neoadjuvant treatment.
  • Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
  • Severe other contradictions of surgery.
  • Pregnant women will be excluded.
  • Exit Criteria:
  • The patient suffered from massive hemorrhage.
  • The operation mode needs to be changed according to the patient's condition.

结局指标

主要结局

Change of circulating tumor cells during laparoscopic or transanal endoscopic surgery

时间窗: 1 years

To determine the changes of circulating tumor cells in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection before operation and 5 days after operation.

次要结局

  • Disease free survival(3 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Deng

Sun Yat-sen University

Sun Yat-sen University

研究点 (1)

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