NCT04759820Unknown2 期
A Multicentre Randomized Controlled Clinical Study of the Efficacy of Carbon Nanoparticles Versus Indocyanine Green in Surgical Treatment of Colorectal Cancer
LI XIN-XIANG1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Number of lymph nodes detected
研究概览
简要总结
Both nano carbon and ICG as lymph node tracers in colorectal cancer have their own value, this study was to contrast two tracers in colorectal cancer surgeries, so as to find out the best lymphnode tracer in colorectal cancer, in order to further improve postoperative lymph node inspection, precise postoperative adjuvant therapy and improve the patients' long-term survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer was confirmed by preoperative fibrocolonoscopy and pathological examination;
- •The operative requirements of the patients included in the study: laparoscopic radical surgery of colon/rectal cancer, indocyanine green group should be used fluorescent laparoscopic (Pinpoint) surgery;
- •The lower edge of the lesion is located more than 10cm from the anus;
- •Age 18 ~ 70;
- •The results of laboratory examination before enrollment met the following surgical conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/ dL), alanine aminotransferase (ALT), ascarate aminotransferase (AST) ≤2× upper limit of normal;The coagulation parameters were in the normal range.
- •Patients had no psychological, family, social, or geographical constraints that affected protocol compliance and follow-up time
- •Patient signs informed consent;
排除标准
- •Under 18 years old or above 70 years old;
- •Other types of colorectal cancer (adenosquamous cell carcinoma, squamous cell carcinoma, neuroendocrine tumor, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma)
- •Rectum cancer less than 10cm from the anus;
- •Previous abdominal surgery;
- •Neoadjuvant therapy was received preoperatively, including radiotherapy and chemotherapy;
- •Due to various reasons, preoperative colonoscopic injection of carbon nanoparticles/indocyanine green labeling was not possible;
- •Intraoperative radical surgery cannot be performed due to various reasons;
- •Acute abdomen: intestinal obstruction, intestinal wringing, peritonitis, etc.;
- •Combined with other site metastasis;
- •Have severe heart, lung, liver and kidney diseases and cannot tolerate surgery;
- •Active stage of liver disease or abnormal liver function, ALT, AST, TBIL more than twice the upper limit of normal value;
- •Renal function impairment, Cr≥2 times the upper limit of normal or BUN≥2 times the upper limit of normal;
- •The subjects' white blood cells are lower than the lower limit of normal value, or their platelets are lower than the lower limit of normal value, or have other diseases of the blood system;
- •People with mental illness or mental retardation who cannot describe their feelings correctly;
- •Severe disorder of coagulation mechanism and bleeding tendency;
- •Have a history of serious uncontrolled medical disease or recent myocardial infarction (within 3 months);Acute infection;
- •Patients with uncontrolled severe hypertension and severe diabetes after intervention treatment;
- •Allergic to the test drug;
- •A history of alcohol, drug or substance abuse;
- •Participants who had participated in any drug trial within 3 months prior to enrollment;
- •Other subjects considered by the researcher to be unsuitable for inclusion in this study.
研究组 & 干预措施
Nano carbon group
Experimental
Injection of carbon nanoparticle
干预措施: injecting Carbon Nanoparticles Suspension (Drug)
Indocyanine green group
Active Comparator
Injection of indocyanine green
干预措施: Injecting indocyanine green (Drug)
结局指标
主要结局
Number of lymph nodes detected
时间窗: 1 week after surgery
Number of positive lymph nodes detected at different T stages
时间窗: 1 week after surgery
the ratio of positive lymph nodes
时间窗: 1 week after surgery
次要结局
- patients' Disease-Free Survival(DFS)(1 year after surgery)
研究者
LI XIN-XIANG
Professor
Fudan University
研究点 (1)
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