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临床试验/NCT06516796
NCT06516796已完成不适用

Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size

Liang Chen1 个研究点 分布在 1 个国家目标入组 2,713 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,713
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer (NSCLC). This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC.

Patients with small-sized (≤2 cm) NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened.

详细描述

Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer (NSCLC). This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC.

Patients with small-sized (≤2 cm) NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened. The characteristics of patients with nodal metastasis were demonstrated. For selected patients, the perioperative and long-term outcomes of patients with and without lymphadenectomy were compared. Log-rank test and Cox regression analysis were adopted for prognostic evaluation.

A total of 2713 NSCLC patients were enrolled, and 75 of them (2.76%) had nodal involvement. None of patients with pure ground glass opacity (0/945) had nodal metastasis, while 14 patients with part-solid (14/1260, 1.11%) and 61 patients with solid nodules (61/508, 12.01%) had nodal involvement. Patients with nodal metastasis had a minimum solid size of 6 mm. NSCLC with solid components < 6 mm (n=1588) had no nodal metastasis. Of them, 339 patients underwent sublobar resection without lymphadenectomy (SRN0), 1056 subjects received sublobar resection with lymphadenectomy (SRN1), and 190 patients received lobectomy plus lymphadenectomy (LRN1). Patients with SRN0 had a shorter operating time, less volume of drainage, a lower incidence of chylothorax (0 vs. 0.6% vs. 2.1%, P=0.012) and air leakage, as well as a shorter postoperative hospitalization (3 vs. 4 vs. 4 days, P<0.001) than those with SRN1 or LRN1. During a median follow-up of 61 months, no patient with SRN0 was dead or tumor recurrent. The 5-year recurrence-free survival was 100%, 99.2% and 98.5% for patients with SRN0, SRN1 and LRN1, respectively (P=0.370).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • pathologically confirmed non-small cell lung cancer (NSCLC)
  • the maximum tumor diameter ≤2 cm
  • receiving surgical treatment between 2009-2022

排除标准

  • non-primary NSCLC;
  • with small cell lung cancer components;
  • undergoing preoperative neoadjuvant therapies;
  • with compromised resection;
  • malignant tumor history over the past five years.

结局指标

主要结局

Overall survival (OS)

时间窗: OS was defined from the surgical date to the date of death or the date of the last follow-up, whichever came first, assessed up to 14 years.

OS was defined from the surgical date to the date of death or the date of the last follow-up. defined from the surgical date to the date of death or the date of the last follow-up.

次要结局

未报告次要终点

研究者

发起方
Liang Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liang Chen

Director, Head of Thoracic Surgery

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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