Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The positive rate of sentinel lymph node
研究概览
简要总结
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically.
It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors.
Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes.
This will be one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.
This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.
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
- •18 years old ≤ age ≤ 75 years old, gender is not limited;
- •patient who is diagnosed with ESCC and choose to proceed with surgery
- •patient with cTNM stage:T1-3N0-1M0
- •tumor located at the middle thoracic or lower thoracic esophagus
- •The main organ function is basically normal: Karnofsky score >70%;
- •Laboratory blood tests meet surgical standards;
排除标准
- •pregnancy or breastfeeding
- •history of iodide or seafood allergy,
- •Patient with occult metastatic disease at the time of surgery
- •patient with mental disorder;
- •Patient who is simultaneously involved in another clinical trial;
研究组 & 干预措施
use of indocyanine green
submucosal injection of ICG is by gastroscopy on the superior and inferior edge of the esophageal tumor,Dose of 0.5mg
干预措施: Indocyanine Green for Injection (Drug)
结局指标
主要结局
The positive rate of sentinel lymph node
时间窗: through study completion, an average of 1 year
the positive rate of sentinel lymph node in all the enrolled patients
the detection rate of sentinel lymph node
时间窗: through study completion, an average of 1 year
the detection rate of sentinel lymph node in all the enrolled patients
次要结局
未报告次要终点