Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.
研究概览
简要总结
Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA) study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment. The pretreatment clinical variables potentially associated with the procedure will also be analyzed.
To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.
详细描述
Comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction, particularly in advanced GC. Recent data on the sentinel node (SN) concept in early GC has shown favorable results regarding LN detection rate and clinical status determination. Staging laparoscopy (SL) with lavage cytology provides an additional value to the clinical staging of GC, particularly in detecting occult peritoneal disease. The role of Indocyanine green (ICG) guided SN mapping in GC confirmed its technical feasibility. ICG can be safely used to identify SN, determine the surgical resection line, improve the LN harvest, and reduce noncompliance in patients undergoing D2 lymphadenectomy.
The majority of the studies focused on the aspect of the increase in LN harvest. At the same time, no data exist regarding its potential role in GC nodal staging. To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
- •Stage II - III disease (cT2-4a, N0-3, M0) based on the pretreatment CT and 8th edition of TNM classification
- •Qualification for SL by the decision of the multidisciplinary tumor board
- •Written informed consent for endoscopy and SL
排除标准
- •Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor board
- •Previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection
- •Distant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CT
- •Technical inability to perform endoscopic ICG injection or ICG injection beyond the submucosa
- •Visual inability to identify the SN during SL
- •Positive cytology (cyt+) after SL
- •Other malignancies
- •History of allergy to iodine agents
结局指标
主要结局
The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.
时间窗: Up to 2 weeks after inclusion in the study, during staging laparoscopy
The identification rate will allow confirmation of the safety and feasibility of ICG-guided SN biopsy during staging laparosocpy in advanced GC patients
次要结局
- Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy(Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy)
- Pathological status of the retrieved sentinel node(Up to 2 weeks after staging laparoscopy)