Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- False negative rate
研究概览
简要总结
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 from 18 to 75 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
- •No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- •Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- •American Society of Anesthesiology score (ASA) class I, II, or III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- •History of other malignant disease within past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •Forced expiratory volume in 1 second (FEV1)<50% of predicted values
- •Rejection of laparoscopic resection
- •Preoperatively confirmed tumors invading the dentate line or duodenum
- •History of allergy to iodine agents
- •Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy
研究组 & 干预措施
Experimental: Indocyanine Green Tracer
Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
False negative rate
时间窗: One month after surgery
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
次要结局
- False positive rate(One month after surgery)
- Number of Metastasis Lymph Nodes(One month after surgery)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- 3-year recurrence pattern(36 months)
- Time to first flatus(30 days)
- Total number of retrieved lymph nodes(One month after surgery)
- Lymph node noncompliance rate(One month after surgery)
- 3-year overall survival rate(36 months)
- 3-year disease free survival rate(36 months)
- The variation of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
- True positive rate(One month after surgery)
- True negative rate(One month after surgery)
- Metastasis rate of lymph node(One month after surgery)
- Morbidity and mortality rates(One month after surgery)
- Intraoperative morbidity rates(1 day)
- Time to first ambulation(30 days)
- Time to first liquid diet(30 days)
- Time to first soft diet(30 days)
- Duration of postoperative hospital stay(30 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University