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Incidence of 107 Lymph Node Metastasis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07165184
Enrollment
1100
Registered
2025-09-10
Start date
2025-07-21
Completion date
2030-07-21
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophagectomy, lymph node metastasis

Brief summary

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

OTHERno intervention was applied as observation study

no intervention was applied as observation study

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of left subcarinal lymph node metastasis2 yearsnumber of patients who had subcarinal lymph node metastasis/number of patients who had resection of subcarinal lymph node

Secondary

MeasureTime frameDescription
Risk factors of subcarinal lymph node metastasis2 yearsrisk factors that related to the metastasis of subcarinal lymph node.
Survival of patients with subcarinal ymph node metastasis3 yearsthe disease-free survival and overall survival of patients who had subcarinal lymph node metastasis

Countries

China

Contacts

Primary ContactBin Li, MD
lb0256327@hotmail.com086-021-64175590-82500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026