Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Positive ICG fluorescence lymph nodes
研究概览
简要总结
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients ≥ 18 and ≤ 75 years of age.
- •Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
- •Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
- •No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
- •American Society of Anesthesiology score (ASA) class I, II, or III.
- •Written informed consent.
排除标准
- •Patients ≤ 18 and ≥ 75 years of age.
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
- •History of allergy to iodine agents.
- •History of other malignant disease within past five years.
- •Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
- •Patients intraoperatively/postoperatively confirmed as T4b.
- •Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
研究组 & 干预措施
Intervention
Injection of Indocyamine Green.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Positive ICG fluorescence lymph nodes
时间窗: Approximately 30-90 days after surgery
Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
Disease positive lymph nodes
时间窗: Approximately 30-90 days after surgery
Number of ICG positive lymph nodes that are also positive for disease
Number of lymph nodes removed for each lymphatic station of gastrectomy
时间窗: Approximately 30-90 days after surgery
Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG
次要结局
未报告次要终点
研究者
Enrique F. Elli
Principal Investigator
Mayo Clinic