跳至主要内容
临床试验/NCT07242053
NCT07242053进行中(未招募)不适用

Efficacy of Intraoperative CT Feedback of Wedge Resected Lung for the Assessment of Surgical Margin

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
The contribution of intraoperative feedback to treatment decision, and its validity

研究概览

简要总结

To date, there is no established method for confirming whether sufficient margins have been obtained during surgery, only post-surgery by a pathologist. The purpose of this study is to evaluate the impact of intraoperative CT margin feedback on surgical decisions, such as additional removal. The ability to accurately evaluate surgical margins intraoperatively could reduce the risk of locoregional recurrence and eliminate the need for additional treatment after surgery. Moreover, optimal intraoperative feedback to surgeon could influence surgical decision making and contribute to the satisfactory outcome. This is a single center clinical trial. A total of 80 patients scheduled for wedge resections for lung malignancies (including suspected patients) will be enrolled in this study. Nine surgeons in the division of thoracic surgery will also be involved as participants. Once the wedge resection is performed, the resected specimen will be inflated and scanned by CT to measure surgical margin intraoperatively. Surgeons will have access to the CT data and the associated margin data immediately. They then may decide if an additional resection is required. The expected margin surveyed by questionnaire will be compared to CT measured margin, and CT measured margin will be compared to pathological margin questionnaires over course. After the total course of surgery, surgeons will be asked to complete a questionnaire as well to assess the satisfaction by intraoperative feedback.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Patients scheduled for wedge resection for lung malignancies (included suspected lesions).
  • 18 years of age or older.

排除标准

  • Any patients with inability to give informed consent
  • Wedge resection for non-therapeutic purpose, e.g. diagnostic purpose.

研究组 & 干预措施

Intraoperative CT of resected lung

Experimental

干预措施: Intraoperative CT of resected lung (Other)

结局指标

主要结局

The contribution of intraoperative feedback to treatment decision, and its validity

时间窗: 2 years

After the total course of surgery, we will ask each surgeon individually for questionnaire 3 after feedback of the individual result of this study to assess the satisfaction by intraoperative feedback.

次要结局

未报告次要终点

研究者

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

Kazuhiro Yasufuku

Dr. Kazuhiro Yasufuku

University Health Network, Toronto

研究点 (2)

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