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临床试验/NCT01985659
NCT01985659Unknown不适用

Cohort Analysis of Nodal Upstaging in the Era of Increase of VATS Anatomical Resections for NSCLC

University Hospital, Gasthuisberg1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
900
试验地点
1
主要终点
proportion of N upstaging

研究概览

简要总结

This study investigates peropeative nodal upstaging during anatomical resections for non-small-cell-lung-cancer in an era of rising numbers of VATS anatomical resections. In case of comparable study groups, unchanged pretreatment staging and equal quality of pathologic examination, lymph node upstaging is a marker of surgical quality and can be used to study the quality of a new surgical technique.

详细描述

Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure is believed to achieve equal oncologic results and survival, perhaps better.

Publications have shown that mediastianal lymph node dissection during VATS is similar.

However, two recent reports have shown potential lower N1 (hilar and intrapulmonary) upstaging in VATS surgery After optimal staging the percentage of unforeseen N+ the percentage of unforeseen positive nodes can reach 15%

Nodal upstaging at final pathology is dependent on the quality of:

  • pretreatment staging, the better, the less upstaging
  • surgery, ie mediastinal, hilar and intrapulmonary lymphadenectomy
  • pathologic examination If we accept that pretreatment staging and pathologic examination are equal in two comparable surgical cohorts, the finding of unforeseen N+ or nodal upstaging is a quality marker of surgery. When surgical techniques are changing, it is important to look at this marker.

研究设计

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

入排标准

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

入选标准

  • All cN0, cN1 patients that underwent segmentectomy, lobectomy, sleeve lobectomy for NSCLC.

排除标准

  • Pneumonectomy
  • Previous lung cancer surgery - lymphadenectomy
  • Neo-adjunvant therapy
  • Bilateral lesions

结局指标

主要结局

proportion of N upstaging

时间窗: at time of surgical resection

clinical N0 to pathological N1 clinical N0 to pathological N2 clinical N1 to pathological N2

次要结局

未报告次要终点

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

RN, MScN

University Hospital, Gasthuisberg

研究点 (1)

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