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临床试验/NCT07165210
NCT07165210招募中不适用

A Prospective Observational Study of Left Tracheobronchial 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 1,852 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
1,852
试验地点
1
主要终点
Incidence of left tracheobronchial lymph node metastasis

研究概览

简要总结

the study was to document the incidence of left tracheobronchial lymph node metastasis, and the risk factors of metastasis.

详细描述

Although the survival of esophageal cancer patients has improved with the application of chemotherapy, radiotherapy, and immunotherapy, esophageal surgery remains one of the procedures with a high risk of postoperative complications, despite significant advancements in surgical techniques in recent years.

curative surgery includes tumor resection, digestive tract reconstruction, and thorough lymph node dissection. Our previous studies demonstrated that complete right thoracic lymph node dissection significantly improves long-term survival compared to incomplete left thoracic dissection (1). However, extended three-field lymph node dissection did not show survival benefits over conventional two-field dissection (2). Therefore, the precise scope of two-field lymph node dissection in esophageal cancer requires further refinement.

Current preoperative diagnostic methods for lymph node metastasis in esophageal cancer suffer from limited sensitivity (3). In traditional two-field dissection, removing the left tracheobronchial lymph nodes may compromise blood supply to the trachea and bronchi, increase the risk of recurrent laryngeal nerve injury, and elevate postoperative complications such as cough and pneumonia. Our retrospective study on left tracheobronchial lymph node (106TBL) metastasis revealed a low transfer rate of approximately 2% (4). The risk factors for 106TBL metastasis and its long-term prognostic impact remain unclear, necessitating prospective studies to validate the necessity of this nodal station dissection.

This study aims to prospectively investigate the incidence and risk factors of tracheobronchial lymph node metastasis within the conventional dissection range, providing robust evidence for personalized treatment strategies in esophageal cancer.

Reference:

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 tracheobronchial lymph node metastasis

时间窗: 2 years

number of patients who had left tracheobronchial lymph node metastasis/number of patients who had resection of left tracheobronchial lymph node

次要结局

  • Risk factors of left tracheobronchial lymph node metastasis(2 years)
  • Survival of patients with left tracheobronchial lymph node metastasis(5 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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