Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- operative time
研究概览
简要总结
The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.
详细描述
CT three-dimensional reconstruction was performed for middle-low patients who had enlarged lateral lymph node before surgery. The main purpose is to recognize the track and variance of pelvic and iliac blood vessels. The investigators want to explore whether this method can help reduce operative time, unexpected injuries and blood loss, and The investigators also want to study whether it can help improve the lymph node harvested and positive rate during lateral lymph node dissection. Besides, The investigators want to perform node-by-node for enlarged lateral lymph node and CT three-dimensional reconstruction can help the investigators to localize and label the interested lymph node during operation. After node-by-node, The investigators can explore the accuracy of radiologists' and surgeons' judgement for lateral lymph node metastasis, and The investigators also want explore the best cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The investigators want to perform texture analysis by combination radiology and pathology to find some useful parameters to predict lateral lymph node metastasis.
The investigators also want to explore the feasibility of dissecting the unilateral visceral branch of internal iliac vessels when performing lateral lymph node dissection.
The investigators will have a close follow-up for patients who have enlarged lateral lymph node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional reconstruction can help The investigators recognize which parts' lateral lymph nodes have more potential possibility to metastasis and recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •confirmed rectal cancer; 2) tumor located less than 10 cm from the anus verge; 3) have enlarged lateral lymph on preoperative CT/MRI
排除标准
- •patients who have severe liver or renal dysfunction;
研究组 & 干预措施
intervention group
All patients receive CT three-dimensional reconstruction before surgery.
干预措施: CT three-dimensional reconstruction (Radiation)
control group
All patients did not receive CT three-dimensional before surgery
结局指标
主要结局
operative time
时间窗: 2 year
including total operative time and that for lateral lymph node
Blood loss
时间窗: 2 year
intraoperative blood loss
lateral lymph node harvested
时间窗: 2 year
lateral lymph node harvested
Cut-off value of shorter diameter
时间窗: 2 year
The best cut-off value of shorter diameter for lateral lymph node dissection
postoperative complication
时间窗: 2 year
including urinary and sexual function
vessels variances
时间窗: October 1. 2018-December 31.2020
The blood vessels variance of internal iliac vessels
Accuracy of judgement for lateral lymph node metastasis
时间窗: 2 year
including radiologists' and surgeons' accuracy
次要结局
- overall survival(3 year)
- local recurrence rate(3 year)
- disease-free survival(3 year)
研究者
Ziqiang Wang,MD
Clinical professor
West China Hospital
