A Randomized Controlled Trial of Fluorescence Laparoscopic Navigation of the Extent of Lymph Node Dissection for High Rectal Cancer and Sigmoid Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 550
- 试验地点
- 19
- 主要终点
- Disease-free survival
研究概览
简要总结
To explore the short-term and long-term outcomes of fluorescence laparoscopic navigation D2 lymph node dissection for colorectal cancer surgery by comparing it with D3 lymph node dissection.
详细描述
Lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. Therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. In patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. In patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. There is still some controversy over whether to choose D3 lymph node dissection or D2 lymph node dissection for rectal and sigmoid cancer. Fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery.
This study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation D2 and D3 lymph node dissection by conducting a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are aged 18-75;
- •Colonoscopy biopsy confirms colorectal adenocarcinoma;
- •Colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis;
- •The tumor is staged cT1-4aNxM0 by preoperative imaging;
- •Participants have no local complications before surgery.
排除标准
- •Previous history of malignant colorectal tumor;
- •Multiple primary colorectal tumors;
- •Preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253);
- •Patients undergoing neoadjuvant therapy before surgery;
- •With contraindications to laparoscopic surgery;
- •Histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions;
- •Other malignancies were diagnosed within the past 5 years;
- •History of severe mental illness;
- •Pregnant or lactating women;
- •With uncontrolled infection before surgery.
结局指标
主要结局
Disease-free survival
时间窗: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 36 months.
Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.
Overall survival
时间窗: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 36 months.
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
次要结局
- The number of lymph node resection(Until the pathological result is available , an average of 14 days.)
- Blood loss(Until the end of the operation, an average of 8 hours.)
- Complications(Until the patient recovered and was discharged from the hospital, an average of 10 days.)
- Hospital stay after surgery(Until the patient recovered and was discharged from the hospital, an average of 10 days.)
- Function score(Until one year after the patient's surgery)
研究者
Jianqiang Tang
Associate professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences