NCT06396806Enrolling By Invitation不适用
A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,072 人开始时间: 2024年5月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,072
- 试验地点
- 1
- 主要终点
- Disease-free survival rate
研究概览
简要总结
he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0，T1-T4a N+ M0).
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
- None
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
- •Age between 18 and 75 years old
- •Confirmed sigmoid adenocarcinoma cancer pathologically
- •Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin.
- •CT showed sigmoid colon cancer: T3-4a N+ M0
- •Patients with non-local recurrence or distant metastasis;
- •no multiple colorectal cancer;
- •no neoadjuvant therapy;
- •physical conditions such as heart, lung, liver and kidney function can tolerate surgery.
- •Willing and able to provide written informed consent for participation in this study
排除标准
- •Complicated with other malignant tumors or previous history of malignant tumors;
- •patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- •patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
- •patients with poor anal function and incontinence before operation;
- •patients with inflammatory bowel disease or familial adenomatous polyposis
- •ASA grade ≥ IV and / or ECOG physical status score > 2;
- •patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;
- •history of severe mental illness;
- •pregnant or lactating women;
- •patients with uncontrolled infection before operation;
- •patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.
结局指标
主要结局
Disease-free survival rate
时间窗: 3 years after the surgery
odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
次要结局
- Negative rate(14 days after the surgery)
- mortality rate(30 days after the surgery)
- Minimal Residual Disease, MRD(3 years after the surgery)
- The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate(3 years after the surgery)
- Number of Metastasis Lymph Nodes(14 days after the surgery)
- The rate of fluorescence(14 days after the surgery)
- Total number of retrieved lymph nodes(14 days after the surgery)
- The number of lymph nodes at each station(14 days after the surgery)
- Positive rate(14 days after the surgery)
- False positive rate(14 days after the surgery)
- False negative rate(14 days after the surgery)
- Morbidity rate(30 days after the surgery)
- 5-year Overall survival rate(5 years after the surgery)
- Pathological outcomes checklist(14 days after the surgery)
- 3-year Overall survival rate(3 years after the surgery)
- 5-year Disease-free survival rate(5 years after the surgery)
- Local recurrence rate(3 years after the surgery)
- Postoperative function (voiding function, sexual function) and quality of life(3 years after the surgery)
研究者
Yanhong Deng
Chief physician，Assistant to the dean
Sun Yat-sen University
研究点 (1)
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