The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- False positive rate of lymph node dissection
研究概览
简要总结
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.
详细描述
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.
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 and gender: 18-75 years old, male and female unlimited;
- •Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
- •Preoperative combination with neoadjuvant chemoradiotherapy;
- •Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
- •Heart, lung, liver and kidney functions can tolerate operation;
- •Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.
排除标准
- •Allergic to ICG or iodine;
- •Patients with a history of chest surgery or thoracic lymph node dissection;
- •Patients needing emergency surgery;
- •Patients whose tumors involve neighboring organs and need to be removed by combining organs;
- •Patients with tumor recurrence or distant metastasis;
- •Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
- •A history of serious mental illness;
- •Pregnant or lactating women;
- •Patients with other conditions considered by the researcher should not participate in the study.
研究组 & 干预措施
NIR-ICG
After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.
干预措施: Indocyanine green solution (Drug)
结局指标
主要结局
False positive rate of lymph node dissection
时间窗: 1 week after operation
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
False negative rate of lymph node dissection
时间窗: 1 week after operation
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Accuracy rate of lymph node dissection
时间窗: 1 week after operation
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
Sensitivity and specificity of lymph node dissection
时间窗: 1 week after operation
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
次要结局
- The mapping of sentinel lymph nodes in esophageal cancer(1 week after operation)