Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:
1. In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection? 2. In ESCC patients undergoing surgery, can reducing lymph node dissection decrease postoperative complications such as chylothorax and weakened immunity? During the study, ICG will be injected around the tumor under intraoperative gastroscopy guidance, followed by tracking of fluorescent lymph nodes using a thoracoscopic near-infrared camera. Professional thoracic surgeons will group and mark these lymph nodes for intraoperative frozen pathology. Subsequent CLND and routine postoperative pathology will be performed. This study will collect patients' clinical information, ICG imaging results, pathological examination results, and other data for statistical analysis to assess the sensitivity and negative predictive value (NPV) of the ICG imaging system. If the study results support the effectiveness of the ICG imaging system, it has the potential to become an important tool for sentinel lymph node localization and biopsy in future ESCC surgeries, helping to reduce unnecessary lymph node resection and improve surgical efficiency and safety.
Participants will:
1. Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day. 2. Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery. 3. Have perioperative, postoperative pathology, and complication information recorded. 4. Undergo standardized follow-up after surgery.
Age and gender: 18-75 years old, male and female unlimited;
Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
Preoperative combination with neoadjuvant chemoradiotherapy;
Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
Allergic to ICG or iodine;
Patients with a history of chest surgery or thoracic lymph node dissection;
Patients needing emergency surgery;
Patients whose tumors involve neighboring organs and need to be removed by combining organs;
Parallel
Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node
DrugA multicenter, prospective cohort study will be conducted. Enrolled patients with esophageal squamous cell carcinoma will undergo minimally invasive radical esophagectomy. During surgery, ICG will be injected around the tumor under gastroscopy guidance, and fluorescent lymph nodes will be tracked using a thoracoscopic near-infrared camera. These lymph nodes will be grouped and marked by professional thoracic surgeons, and intraoperative frozen pathology results will be recorded. Subsequent CLND will be performed. The study will collect and analyze patients' clinical information, ICG imaging results, and pathological examination results to explore the effectiveness of the ICG imaging system.
Accuracy rate of lymph node dissection
According to postoperative pathological results, investigate the detection rate of metastatic lymph nodes using the near-infrared indocyanine green fluorescence imaging system in lymph node dissection for esophageal squamous cell carcinoma
Sensitivity and specificity of lymph node dissection
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
The number of lymph nodes
The number of lymph nodes between the both groups
False positive rate of lymph node dissection
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
False negative rate of lymph node dissection
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
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Fujian Medical University Union Hospital
Lead sponsor
Henan Cancer Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
The University of Hong Kong
Collaborator
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