NCT06485609招募中不适用
A Prospective, Randomized, Open, Parallel-controlled, Superiority Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2024年8月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Disease-free survival rate
研究概览
简要总结
The purpose of this study is to explore the clinical outcomes of indocyanine green fluorescence using in laparoscopic radical right hemicolectomy for right colon cancer（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
- •1. Age between 18 and 75 years old
- •Confirmed adenocarcinoma cancer pathologically
- •Location of tumor: from the cecum to the right third of the transverse colon
- •CT showed right colon cancer: T1-T4a N+ M0
- •ASA scores I-III
- •ECOG (Eastern Cooperative Oncology Group) scale performance status of 0 or 1
- •Patient or family member, able to understand the study protocol and willing to participate in the study, providing written informed consent
排除标准
- •1. Simultaneous or heterochronic multiple primary colon cancer
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery
- •Unsuitable for laparoscopic surgery (e.g., extensive adhesions due to previous major abdominal surgery; unsuitable for pneumoperitoneum for various reasons, etc.)
- •Pregnant or lactating women
- •Have a history of serious mental illness
- •History of iodine allergy
- •History of other malignant diseases within the last five years
- •History of prior neoadjuvant chemotherapy or radiation therapy
- •History of unstable angina or myocardial infarction within the last 6 months
- •History of continuous systemic corticosteroid use within one month
结局指标
主要结局
Disease-free survival rate
时间窗: 3 years
次要结局
- Number of lymph nodes cleared(Immediately after surgery)
研究者
Yanhong Deng
chief physician
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (1)
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