NCT03854890Unknown不适用
Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The total number of lymph nodes retrieved
研究概览
简要总结
The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.
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
- •Histologically confirmed diagnosis of rectal carcinoma.
- •Without multiple primary cancer.
- •Without receiving neoadjuvant chemoradiotherapy.
- •Sufficient organ function.
- •Able to provide written informed consent.
排除标准
- •Younger than 18 years or older than 75 years
- •Synchronous or metachronous malignancy within 5 years.
- •Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- •Patients with a history of pelvic irradiation.
- •ASA (American Society of Anesthesiologists) grade IV or V.
- •Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
- •Severe mental illness.
- •Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
- •Patients who received steroid therapy within one month.
- •Patients or family members misunderstand the conditions and goals of this study.
研究组 & 干预措施
Lymphadenectomy with indocyanine green injection
Experimental
Injection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
The total number of lymph nodes retrieved
时间窗: During the surgery
The positive number of lymph nodes retrieved
时间窗: During the surgery
次要结局
- Detection rate of indocyanine green-positive para-aortic lymph node(During the surgery)
- The duration of the operation to remove the lymph nodes(During the surgery)
研究者
研究点 (1)
Loading locations...
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