A Non-inferiority Study of Indocyanine Green-guided Sentinel Lymph Node Mapping Versus Conventional Lymph Node Dissection in Esophageal Cancer

This study will enroll patients with cT1-3N0M0 esophageal cancer who have not received neoadjuvant therapy. If intraoperative frozen section shows negative sentinel lymph nodes, patients will be randomly assigned into two groups: the experimental group will undergo sentinel lymph node dissection only plus esophagectomy, while the control group will undergo conventional lymph node dissection plus esophagectomy. The investigators will compare the 3-year disease-free survival rate, postoperative complication rate, and other outcomes between the two groups to evaluate the oncological safety of sentinel lymph node dissection based on the ICG near-infrared fluorescence imaging system in radical esophagectomy for esophageal cancer.

Inclusion criteria

• Aged 18 to 75 years, regardless of gender;
• Histopathologically confirmed esophageal squamous cell carcinoma or adenocarcinoma by endoscopic biopsy (including esophagogastric junction carcinoma, Siewert type I/II);
• Preoperative clinical stage cT1-3N0M0 (based on contrast-enhanced CT ± PET-CT ± endoscopic ultrasound evaluation);
• No prior neoadjuvant therapy of any form (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, targeted therapy, etc.);
• Scheduled for minimally invasive radical esophagectomy (combined thoracoscopic and laparoscopic McKeown or Ivor-Lewis procedure);
• No surgical contraindications, with cardiac, pulmonary, hepatic, and renal functions sufficient to tolerate surgery;
• ECOG performance status score of 0 to 1;
• Written informed consent signed by the patient or legal representative.

Exclusion criteria

• Preoperative imaging clearly indicating lymph node metastasis (cN+) or distant metastasis (cM1);
• Prior systemic or local treatment for esophageal cancer of any kind (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, etc.);
• Previous history of esophageal or gastric surgery (except endoscopic mucosal resection/submucosal dissection);
• History of allergy to iodine contrast agents or indocyanine green;
• Severe hepatic or renal insufficiency (Child-Pugh class B or C; serum creatinine ≥ 1.5 times the upper limit of normal);
• Uncontrolled hyperthyroidism;
• Concomitant other malignancies requiring simultaneous treatment;
• Pregnant or lactating women;
• Other conditions deemed unsuitable for enrollment by the investigator.

Withdrawal Criteria

• Intraoperative exploration revealing inability to achieve radical resection (R2 resection) or extensive thoracic and abdominal metastasis;
• Intraoperative exploration revealing definite lymph node metastasis (cN+) inconsistent with preoperative staging;
• Severe allergic reaction after ICG injection requiring discontinuation of the study;
• Intraoperative change of surgical plan due to severe complications;
• Withdrawal of informed consent by the patient.