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临床试验/NCT06252129
NCT06252129招募中不适用

Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年7月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Nodal upstage rate

研究概览

简要总结

Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

详细描述

Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes.

Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
  • Subject without any metastasis present.
  • Subjects who have peripheral lung nodule location
  • Subjects must be 18 years of age or older.

排除标准

  • Subjects who received preoperative chemotherapy or radiotherapy.
  • Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.

研究组 & 干预措施

1. Interventional group

Experimental

subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol

干预措施: Subjects undergoing a lung specimen lymph node dissection (Other)

Concurrent non-interventional group

No Intervention

Retrospective cohort from 2021-2020

Other

干预措施: Control group (Other)

结局指标

主要结局

Nodal upstage rate

时间窗: 2 weeks

Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.

Number of lymph nodes sampled

时间窗: 2 weeks

To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.

次要结局

  • 3y RFS(3 years)

研究者

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

Paula Antonia Ugalde Figueroa

Associate Surgeon, Division of Thoracic Surgery, Principal Investigator.

Brigham and Women's Hospital

研究点 (1)

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