The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-02-01

Summary

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.

• Phase: PHASE3

Details

• Lead Sponsor: Fujian Medical University Union Hospital
• Collaborators: Henan Cancer Hospital; The First Affiliated Hospital of Xiamen University; The University of Hong Kong
• Treatments: Minimally Invasive Surgical Procedures