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临床试验/NCT05183945
NCT05183945Unknown不适用

Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil

Xuzhou Central Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Technical success of localization

研究概览

简要总结

Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.

详细描述

Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications.

The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with lung nodules;
  • Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings.

排除标准

  • Lung nodule < 5 mm;
  • Calcification nodules;
  • Lung nodule which decreased in size at time of follow-up;
  • Patients with distant metastases or other severe comorbidities.

结局指标

主要结局

Technical success of localization

时间窗: From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day.

Lung nodule localization is considered technically successful if the coil tail or marked line can be visible during the video-assisted thoracoscopic surgery. procedure

次要结局

未报告次要终点

研究者

发起方
Xuzhou Central Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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