The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:
Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?
Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.
Participants will:
Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.
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
- •Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
- •The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc.
- •There was no contraindication of puncture and cryobiopsy.
- •Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
排除标准
- •The lesion is a mediastinal cyst or abscess.
- •The patient is allergic to lidocaine and midazolam.
- •The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer.
- •Unstable angina pectoris, congestive heart failure, severe bronchial asthma
- •The patient did not agree to participate in this study
- •Participation in other studies within three months without withdrawal or termination will affect the observation of this study
- •The researcher believes that there is any person who is not suitable for the selection
结局指标
主要结局
Diagnostic yield
时间窗: 6 months after the biopsy
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.
次要结局
- Specimen quality(during the procedure)
- Diagnostic sensitivity(6 months after biopsy.)
- Incidence rate of adverse events(7 days after the biopsy)
- Size of specimen(during the procedure)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital