Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.
详细描述
EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information. This study will analyze whether the freezing time influences the diagnostic yield in CB of mediastinal lymphadenopathies. Additionally we will evaluate the influence of the number of biopsies on the diagnostic yield.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy
- •Age between 18 and 90 years
- •Written informed consent after participant's information
排除标准
- •Age < 18 and > 90 years
- •Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- •Contraindication against bronchoscopy (e.g. co-morbidities)
- •Mediastinal abscess or cyst
- •Extraordinary blood supply of the lesion visualized by EBUS bronchoscope
- •INR > 1.5 or Thrombocytes < 100 G/l
- •Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed)
- •Anticoagulation with NOAC within 48 hours before biopsy
- •Pulmonary lesions suspicious of lung carcinoma
研究组 & 干预措施
group 6 sec
EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 6 seconds of cryoprobe freezing time ("group 6sec.") before the biopsy together with the whole EBUS bronchoscope is extracted.
干预措施: Cryobiopsy of lymph nodes group 6 sec (Device)
group 3 sec
EBUS-guided CBs of mediastinal/hilar lymph nodes will be done with 3 seconds of cryoprobe freezing time ("group 3sec.") before the biopsy together with the whole EBUS bronchoscope is extracted.
干预措施: Cryobiopsy lymphnode group 3 sec (Device)
结局指标
主要结局
Diagnostic yield
时间窗: from date of randomization to the time of the first documented results, assessed up to 100 weeks
Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.).
次要结局
- overall rate of suitability for histopathological examination(from the date of randomization to the time of the first documented results, assessed up to 100 weeks)
- the size of the harvested tissue (mm2)(from date of randomization to the time of the first documented results, assessed up to 100 months)
- ), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy(from date of randomization to the time of the first documented results, assessed up to100 weeks)
- time of the procedure(from the date of randomization to the time of the first documented results, assessed up to 100 weeks)