Incidence of 107 Lymph Node Metastasis

Fudan University

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Other: no intervention was applied as observation study

Study type: Observational

Funder types: Other

Identifiers

NCT07165184

ECTOP-2009

Details and patient eligibility

About

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

Full 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

Enrollment: 1,100 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,100 participants in 1 patient group

observation group

Description:

All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.

Treatment:

Other: no intervention was applied as observation study