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临床试验/NCT02730897
NCT02730897已完成不适用

Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC

University Hospital, Gasthuisberg0 个研究点目标入组 956 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
956
主要终点
Incidence of nodal (N1 and N2) upstaging

研究概览

简要总结

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. However, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial VATS feasibility reports

详细描述

After optimal preoperative staging, 10 to 25% of patients with clinical stage I (cStage-I) non-small cell lung cancer (NSCLC) are found to have unforeseen positive lymph nodes during resection.

Central tumors, even if they are smaller than 3cm (cT1), have a higher incidence of both intrapulmonary or hilar (N1) or ipsilateral mediastinal (N2) lymph node involvement in comparison to peripheral lesions.

In a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. Or, it can be used as an instrument to compare different techniques, such as thoracoscopic (VATS) versus open lung resections for lung cancer.

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery. These retrospective studies did not include tumor location.

The investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. This is in line with initial feasibility reports and guidelines that excluded patients with central lesions. This results in a higher prevalence of positive N1 nodes in patients operated with the open approach.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients operated in 2014
  • NSCLC on final pathology
  • cStage-I (cT1-2a cN0 cM0 ) before start of incision for anatomical resection.
  • This includes: open/VATS/ Robotic Assisted Thoracoscopic Surgery (RATS)
  • This includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge)

排除标准

  • Higher clinical stage than cStage-I
  • Former therapy for lung cancer (chemotherapy, radiotherapy, surgery)
  • Metastatic disease
  • Induction chemo- or radiotherapy
  • Non-anatomical resections (wedge)
  • Previous lymph node disease
  • No positron emission tomography (PET) or Missing PET report

结局指标

主要结局

Incidence of nodal (N1 and N2) upstaging

时间窗: immediate postoperative

Incidence of nodal (N1 and N2) upstaging stratified by 'central' versus 'peripheral' tumor location

次要结局

  • Overall Survival(1 yr postoperative)

研究者

发起方
University Hospital, Gasthuisberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johnny Moons

Clinical Trial Coordinator

University Hospital, Gasthuisberg

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