An observational study in Esophageal Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Fudan University · Observational
the study was to document the incidence of left tracheobronchial lymph node metastasis, and the risk factors of metastasis.
Although the survival of esophageal cancer patients has improved with the application of chemotherapy, radiotherapy, and immunotherapy, esophageal surgery remains one of the procedures with a high risk of postoperative complications, despite significant advancements in surgical techniques in recent years.
curative surgery includes tumor resection, digestive tract reconstruction, and thorough lymph node dissection. Our previous studies demonstrated that complete right thoracic lymph node dissection significantly improves long-term survival compared to incomplete left thoracic dissection (1). However, extended three-field lymph node dissection did not show survival benefits over conventional two-field dissection (2). Therefore, the precise scope of two-field lymph node dissection in esophageal cancer requires further refinement.
Current preoperative diagnostic methods for lymph node metastasis in esophageal cancer suffer from limited sensitivity (3). In traditional two-field dissection, removing the left tracheobronchial lymph nodes may compromise blood supply to the trachea and bronchi, increase the risk of recurrent laryngeal nerve injury, and elevate postoperative complications such as cough and pneumonia. Our retrospective study on left tracheobronchial lymph node (106TBL) metastasis revealed a low transfer rate of approximately 2% (4). The risk factors for 106TBL metastasis and its long-term prognostic impact remain unclear, necessitating prospective studies to validate the necessity of this nodal station dissection.
This study aims to prospectively investigate the incidence and risk factors of tracheobronchial lymph node metastasis within the conventional dissection range, providing robust evidence for personalized treatment strategies in esophageal cancer.
Reference:
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 1,852 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
observation study population
Exclusion Criteria:
All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.
Other: No Intervention: Observational Cohort
no intervention was applied in this cohort
Incidence of left tracheobronchial lymph node metastasis
number of patients who had left tracheobronchial lymph node metastasis/number of patients who had resection of left tracheobronchial lymph node
Time frame: 2 years
Risk factors of left tracheobronchial lymph node metastasis
risk factors that related to the metastasis of left tracheobronchial lymph node.
Time frame: 2 years
Survival of patients with left tracheobronchial lymph node metastasis
the disease-free survival and overall survival of patients who had left tracheobronchial lymph node metastasis
Time frame: 5 years
Plan to share: Yes — incidence, risk factors and survival data could be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Fudan University