NCT05978882尚未招募不适用
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 203
- 试验地点
- 12
- 主要终点
- Detection rate of Sentinel lymph nodes
研究概览
简要总结
SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.
详细描述
- Injection of Indocyanine Green (ICG)
- Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer
- Identification of sentinel basin using fluorescence laparoscopy
- Laparoscopic sentinel basin dissection and identification of sentinel node at the back table
- Surgical considerations
- Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section.
- If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed.
- However, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
- •tumor size: less than 3cm
- •location: 2cm far from the pylorus or cardia
- •aged 20 to 80
- •ECOG 0 or 1
- •patient who signed the agreement
- •patient who is suspected to underwent laparoscopic or robotic gastrectomy
排除标准
- •indication of endoscopic submucosal resection
- •inoperable due to poor cardiac, and pulmonary function
- •having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
- •diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
结局指标
主要结局
Detection rate of Sentinel lymph nodes
时间窗: 15 days after operation
number of patients whose sentinel nodes are detected / enrolled number of patients \*100
次要结局
- 3 year overall survival rate(3 year after surgery)
- 3 year recurrence free survival rate(3 year after surgery)
- scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22(5 years)
- 5 year disease specific death rate(5 years)
- 3 year disease free survival(3 year after surgery)
- 3 year disease specific death rate(3 year after surgery)
- 5 year overall survival rate(5 years)
- 5 year disease free survival rate(5 years)
- 5 year recurrence free survival rate(5 years)
研究者
Hong Man Yoon
MD
National Cancer Center, Korea
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic ResectionSentinel Lymph NodeEarly Gastric CancerNCT03123042National Cancer Center, Korea243
已完成
不适用
Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant ChemotherapySentinel Lymph Node BiopsyNeoadjuvant TherapyBreast NeoplasmNCT06212440National Cancer Center, Korea348
已完成
不适用
Multicenter Phase III Trial of Laparoscopic Sentinel Node BiopsyEarly Gastric CancerNCT01804998National Cancer Center, Korea580
招募中
不适用
Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast CancerRecurrent Breast CancerNCT06329089Hospital Clinic of Barcelona97
已完成
1 期
NIR-Guided Sentinel Lymph-Node Mapping for Esophageal CancerEsophageal CancerNCT01808417Dana-Farber Cancer Institute10