NCT03321994Unknown不适用
A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy
Hyung Jin Won0 个研究点目标入组 106 人开始时间: 2017年11月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 主要终点
- Needle guide accuracy(mm)
研究概览
简要总结
The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT
- •Histopathologic examination is necessary if lung lesion is unknown
- •Histologic findings affect the disease stage or treatment plan
- •If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit
- •Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)
- •Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol
排除标准
- •Patient with pulmonary function insufficiency
- •Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)
- •Patient with Uncontrolled coagulation disorders (INR > 1.3 or Blood platelet count < 50,000/µl)
- •Patient with allergy to CT contrast agent
- •Patient under 19 years old or over 80 years old
- •Pregnant or lactating
- •Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)
- •Patient who currently participating or has participated in other clinical trials within 30 days of the screening date
- •If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
研究组 & 干预措施
Conventional biopsy technique
Active Comparator
干预措施: conventional biopsy technique (Device)
Stereotaxic unit, navigation
Experimental
干预措施: stereotaxic unit, navigation (Device)
结局指标
主要结局
Needle guide accuracy(mm)
时间窗: 1 day
3D distance between target point and actual needle tip
次要结局
- Needle guide angle deviation(°)(1 day)
- Number of needle readjustments(1 day)
- Number of needle reinsertion(1 day)
- Needle insertion time(min)(1 day)
- Procedure time(min)(1 day)
研究者
Hyung Jin Won
Professor
Asan Medical Center
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