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NCT Number: NCT07165210

Incidence of 106TBL Lymph Node Metastasis

the study was to document the incidence of left tracheobronchial lymph node metastasis, and the risk factors of metastasis.

Recruiting

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • Li B, Hu H, Zhang Y, et al. Extended Right Thoracic Approach Compared With Limited Left Thoracic Approach for Patients With Middle and Lower Esophageal Squamous Cell Carcinoma: Three-year Survival of a Prospective, Randomized, Open-label Trial. Ann Surg . 2018 May;267(5):826-832.
  • Li B, Zhang Y, Miao L, et al. Esophagectomy With Three-Field Versus Two-Field Lymphadenectomy for Middle and Lower Thoracic Esophageal Cancer: Long-Term Outcomes of a Randomized Clinical Trial. J Thorac Oncol . 2021 Feb;16(2):310-317.
  • Li B, Li N, Liu S, et al. Does [18F] fluorodeoxyglucose-positron emission tomography/computed tomography have a role in cervical nodal staging for esophageal squamous cell carcinoma? J Thorac Cardiovasc Surg . 2020 Aug;160(2):544-550.
  • Lin K, Li B, Sun Y, et al. Precise pattern of lymphatic spread of esophageal squamous cell carcinoma: results of 1074 patients with N1 disease. J Cancer Res Clin Oncol . 2023 Nov;149(17):15819-15825

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with esophageal squamous cell carcinoma
  • clinical staging: cT1-4a N0/+ M0.
  • no history of other malignancy.

Exclusion criteria

  • esophageal cancer in the neck
  • poor physical status to have esophagectomy.

Treatment and study plan

No Intervention: Observational Cohort

Other

no intervention was applied in this cohort

Primary outcomes

  1. Incidence of left tracheobronchial lymph node metastasis

    Time frame: 2 years

    number of patients who had left tracheobronchial lymph node metastasis/number of patients who had resection of left tracheobronchial lymph node

Secondary outcomes

  1. Risk factors of left tracheobronchial lymph node metastasis

    Time frame: 2 years

    risk factors that related to the metastasis of left tracheobronchial lymph node.

  2. Survival of patients with left tracheobronchial lymph node metastasis

    Time frame: 5 years

    the disease-free survival and overall survival of patients who had left tracheobronchial lymph node metastasis

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective Observational Study of Left Tracheobronchial Lymph Node Metastasis in Patients With Esophageal Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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