Renin-angiotensin System Inhibitor for Preventing Postoperative Recurrence of Stage II/III Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,640
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
The goal of this retrospective cohort study is to learn about the long-term effects of renin-angiotensin system inhibitors (RASi) in preventing patients with hypertension and stage II/III colon cancer from recurrence and metastases after radical resection. The main question it aims to answer is:
Does RASi improve the 3-year disease-free survival of patients with hypertension and stage II/III colon cancer after surgery? Participants with hypertension and already having radical resection of stage II/III colon cancer will be followed up for 3 years.
详细描述
Previous studies have shown that renin-angiotensin system inhibitors (RASi) may reduce postoperative recurrence and metastases of colorectal cancer. However, the relevant clinical evidences were low level and controversial. This study retrospectively collect patients with hypertension and stage II/III colon cancer after radical resection, and compare the patients with vs. without RASi in terms of long-term oncological outcomes, to study the inhibitory effect of RASi on recurrence and metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inferior tumor edge > 15 cm from anal verge;
- •Received radical resection of primary tumor;
- •Pathological proved stage II or stage III adenocarcinoma;
- •No evidence of distant metastases at time of surgery (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, intraoperative exploration, etc;
- •Combined with hypertension at time of surgery;
- •No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
- •Informed consent.
排除标准
- •Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
- •Multiple primary colorectal cancer;
- •Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
- •Co-existent inflammatory bowel disease;
- •Pregnancy or lactation;
- •Received any of preoperative anti-cancer treatment.
研究组 & 干预措施
No renin-angiotensin system inhibitors (No RASi)
Not using RASi after radical resection of stage II/III colon cancer
干预措施: No renin-angiotensin system inhibitors (No RASi) (Drug)
Renin-angiotensin system inhibitors (RASi)
Using RASi after radical resection of stage II/III colon cancer
干预措施: Renin-angiotensin system inhibitors (RASi) (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: 3 years after surgery
The events of 3-year disease-free survival are defined as any recurrence of metastases or death within 3 years after surgery.
次要结局
未报告次要终点
研究者
Xu jianmin
Zhongshan Hospital Fudan University
Fudan University