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NCT Number: NCT07165184

Incidence of 107 Lymph Node Metastasis

the study was to document the incidence o subcarinal lymph node metastasis, and the risk factors of metastasis.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Bin Li, MD

SUB_INVESTIGATOR

Haiquan Chen, MD

CONTACT

[email protected]

+86 13601973588

Haiquan Chen, MD

PRINCIPAL_INVESTIGATOR

About this study

Esophageal cancer remains one of the most prevalent malignancies worldwide, with surgery serving as the cornerstone for resectable cases. Although patient survival has improved with the integration of chemotherapy, radiotherapy, and immunotherapy, esophageal surgery still carries a high risk of postoperative complications despite recent technical advancements. Standard procedures involve tumor resection, digestive tract reconstruction, and comprehensive lymphadenectomy.

Our prior research demonstrated that complete right thoracic lymph node dissection significantly enhances long-term survival compared to incomplete left thoracic dissection (1). However, extended three-field dissection offered no survival advantage over conventional two-field dissection (2), necessitating further refinement of the latter's scope. Current preoperative diagnostics for lymph node metastasis suffer from limited sensitivity (3). During traditional two-field dissection, removing subcarinal lymph nodes (located below the carina) may compromise tracheobronchial blood supply, increasing risks of postoperative cough and pneumonia. Our retrospective study revealed a low subcarinal metastasis rate of approximately 2% (4). The risk factors and long-term prognostic impact of subcarinal metastasis remain unclear, requiring prospective studies to validate the necessity of this nodal station dissection.

This prospective study aims to investigate the incidence and risk factors of subcarinal lymph node metastasis within conventional dissection ranges, 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

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 was applied as observation study

Other

no intervention was applied as observation study

Primary outcomes

  1. Incidence of left subcarinal lymph node metastasis

    Time frame: 2 years

    number of patients who had subcarinal lymph node metastasis/number of patients who had resection of subcarinal lymph node

Secondary outcomes

  1. Risk factors of subcarinal lymph node metastasis

    Time frame: 2 years

    risk factors that related to the metastasis of subcarinal lymph node.

  2. Survival of patients with subcarinal ymph node metastasis

    Time frame: 3 years

    the disease-free survival and overall survival of patients who had subcarinal 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 Subcarinal 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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