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临床试验/NCT05445635
NCT05445635已完成不适用

Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2022年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
Diagnostic yield of bronchoscopy

研究概览

简要总结

Since the beginning of lung screening program in the different countries around the world by chest CT scan, numerous lung nodules and masses of unknown etiology are diagnosed.

Usually, the pathological diagnosis is obtained by bronchoscopy. However, peripheral bronchi cannot be seen after the fifth bronchial division as the diameter of the broncoscope is greated than the diameter of the bronchi. Therefore, the Iriscope was developed. It consists in a thin catheter with a mini-camera at its distal extremity.

The aime of this study is to evaluate the diagnostic yield of bronchoscopy guided by Iriscope in the setting of peripheral lung nodules and masses supect of malignancy, to compare the Iriscope to endobronchial radial ultrasonography (which is a validated technique to guide bronchoscopy in the setting of peripheral lung nodules and masses) and to evaluate the added value on the diagnostic yield by combining these 2 techniques.

研究设计

研究类型
Interventional
分配方式
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
否

入选标准

  • •Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters

排除标准

  • •Any contraindication to general anesthesia
  • •Coagulopathy

研究组 & 干预措施

EBUS

Active Comparator

干预措施: Iriscope (Device)

Iriscope

Experimental

干预措施: Iriscope (Device)

Combined Iriscope + EBUS

Experimental

干预措施: Iriscope (Device)

结局指标

主要结局

Diagnostic yield of bronchoscopy

时间窗: Pathological diagnosis just after the bronchoscopy. In case of unspecified diagnosis after bronchoscopy, a follow up may be performed by chest ct scan up to 6 months.

The diagnosis will be obtained by pathological analysis. The diagnostic yield is the number of cases with a pathological diagnosis obtained by bronchoscopy on the total number of cases. In case of unspecified diagnosis, the fianal diagnosis will be given by the pathological naalysis of the surgical resection or chest CT follow up.

次要结局

  • Complications of bronchoscopy(Just after the bronchoscopy to 1 month after the procedure)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivier Taton

Doctor

Erasme University Hospital

研究点 (1)

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