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临床试验/NCT03617029
NCT03617029Unknown不适用

Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial

National Taiwan University Hospital Hsin-Chu Branch1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Successful localization for surgery

研究概览

简要总结

In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.

Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Deep lung lesions

排除标准

  • Emphysema COPD Previous ilpislateral surgery

研究组 & 干预措施

Microcoil

Experimental

Needle localization for deep-seated lung nodules with microcoil placement

干预措施: Microcoil (Device)

Contrast

Active Comparator

Needle localization for deep-seated lung nodules with contrast injection

干预措施: Lipiodol (Drug)

结局指标

主要结局

Successful localization for surgery

时间窗: 1 day

Localization contribute to surgery

Procedure success rate

时间窗: 1 day

Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.

次要结局

  • Procedure-related complication rate(1 day)
  • Duration of the localization procedure(1 day)
  • Duration of wedge resection(1 day)
  • Surgical margin of wedge resection(1 day)

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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