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临床试验/NCT03826862
NCT03826862Unknown不适用

Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer

Ziqiang Wang,MD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

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

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

Experimental

All patients receive CT three-dimensional reconstruction before surgery.

干预措施: CT three-dimensional reconstruction (Radiation)

control group

No Intervention

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

发起方
Ziqiang Wang,MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ziqiang Wang,MD

Clinical professor

West China Hospital

研究点 (1)

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