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临床试验/NCT07165184
NCT07165184招募中不适用

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

Fudan University1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2025年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,100
试验地点
1
主要终点
Incidence of left subcarinal lymph node metastasis

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Incidence of left subcarinal lymph node metastasis

时间窗: 2 years

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

次要结局

  • Risk factors of subcarinal lymph node metastasis(2 years)
  • Survival of patients with subcarinal ymph node metastasis(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haiquan Chen

Director, Institute of Thoracic Oncology, Fudan University

Fudan University

研究点 (1)

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