Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Granuloma Detection Rate
研究概览
简要总结
The goal of this clinical trial is to compare the diagnostic efficacy and safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy (EBUS-TBMC) versus standard EBUS-guided Transbronchial Needle Aspiration (EBUS-TBNA) in adult patients with suspected mediastinal lymph node tuberculosis. The main questions it aims to answer are:
Does EBUS-TBMC provide a superior diagnostic yield for detecting granulomatous inflammation compared to EBUS-TBNA in the same target lymph node? Does the cryopreservation process affect the viability of Mycobacterium tuberculosis for culture, and does the larger tissue sample obtained via EBUS-TBMC enhance the sensitivity of molecular tests such as Xpert MTB/RIF? Is the safety profile of EBUS-TBMC, particularly regarding bleeding complications, comparable to that of EBUS-TBNA in this patient population? Researchers will compare the two biopsy techniques using a paired design within the same patient to see if EBUS-TBMC results in higher rates of positive pathology, microbiology, and molecular diagnoses.
Participants will:
Undergo both EBUS-TBNA and EBUS-TBMC procedures on the same mediastinal lymph node during a single bronchoscopy session, with the order of procedures randomized.
Provide blood and tissue samples for comprehensive testing, including histology, mycobacterial culture, and Xpert MTB/RIF assay.
Complete short-term (within 2 hours post-procedure) and 7-day follow-up assessments to monitor for any adverse events.
Participate in a 6-month clinical follow-up to establish a final diagnosis, which will serve as the reference standard for evaluating the diagnostic tests.
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
- •Age 18 years or older;
- •Presence of unexplained mediastinal lymphadenopathy (short-axis diameter ≥1 cm on chest computed tomography) with clinical suspicion of tuberculosis;
- •Completion of routine pre-procedural evaluations including blood tests (complete blood count, coagulation profile), electrocardiogram, and chest CT;
- •Absence of contraindications for EBUS-TBNA or EBUS-TBMC procedures;
- •Provision of written informed consent after being fully informed of the study purpose and procedures.
排除标准
- •Known allergy to lidocaine or midazolam;
- •Presence of bronchial artery penetration into the target lesion or high risk of bleeding as detected by contrast-enhanced CT or EBUS Doppler mode prior to the procedure;
- •Unstable angina, congestive heart failure, or severe bronchial asthma;
- •Evidence of significant liquefaction necrosis in the target mediastinal lymph node on pre-procedural CT or EBUS;
- •Patient refusal to participate in the study;
- •Participation in another clinical trial within the past three months that may interfere with the outcomes of this study;
- •Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation
研究组 & 干预措施
EBUS-TBMC
Participants undergoing EBUS-TBMC for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. After locating the target lymph node via EBUS, a tunnel is created using a puncture dilation catheter. The outer sheath is left in place to maintain the tunnel. A cryoprobe is then inserted through the sheath into the lymph node, ensuring the tip is at least 5 mm from the node edge and visible vessels. Freezing is activated using carbon dioxide to obtain tissue samples. A total of three independent cryobiopsy specimens are collected from the same target node. A portion of each specimen is sent for mycobacterial culture and Xpert MTB/RIF testing; the remaining tissue is fixed in formalin for histopathological evaluation. In this paired design study, all participants undergo both EBUS-TBMC and EBUS-TBNA procedures on the same lymph node during a single session, with the sequence determined by randomization.
干预措施: EBUS-TBMC (Procedure)
EBUS-TBNA
Participants undergoing standard EBUS-TBNA for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. Using a 22G EBUS aspiration needle, the target lymph node is punctured under real-time ultrasound guidance. Standard "to-and-fro" movements are performed approximately 30 times per pass. A total of five independent needle passes are performed on the same target node. The first pass specimen is collected directly into sterile saline for mycobacterial culture. The remaining specimens are rinsed into formalin for cell block preparation. The rinsing fluid from the needle and specimen container is also collected for Xpert MTB/RIF testing and culture. In this paired design study, all participants undergo both EBUS-TBNA and EBUS-TBMC procedures on the same lymph node during a single session, with the sequence determined by randomization.
干预措施: EBUS-TBNA (Procedure)
结局指标
主要结局
Granuloma Detection Rate
时间窗: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)
The proportion of patients in whom granulomatous inflammation is detected on histopathological examination of the biopsy specimens obtained from the target mediastinal lymph node. Assessment will be performed by pathologists blinded to the biopsy technique used for each specimen.
次要结局
- Mycobacterium tuberculosis Culture Positivity Rate(Up to 6 weeks post-procedure (standard mycobacterial culture reporting time))
- Acid-Fast Bacilli (AFB) Smear Positivity Rate(Within 1 week post-procedure)
- Xpert MTB/RIF Ultra Positivity Rate(Within 3 days post-procedure)
- Procedure-Related Complication Rate(From start of procedure through 7 days post-procedure)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital