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Recruiting NCT07165184

Incidence of 107 Lymph Node Metastasis

Observational Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention was applied as observation study.
Who it may be relevant to
Registry conditions: Esophageal Cancer. Basic parameters: 20 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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:

1. 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. 2. 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. 3. 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. 4. 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

Interventions

  • Other no intervention was applied as observation study
    no intervention was applied as observation study

Primary outcome measures

  • Incidence of left subcarinal lymph node metastasis [Time frame: 2 years]
Secondary outcome measures (2)
  • Risk factors of subcarinal lymph node metastasis [Time frame: 2 years]
  • Survival of patients with subcarinal ymph node metastasis [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07165184 · ECTOP-2009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗