Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial

Обзор

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.

Вмешательства

• Процедура EBUS-TBMC
  EBUS-TBMC is a minimally invasive bronchoscopic procedure performed under moderate sedation or general anesthesia to obtain larger and more intact tissue samples from mediastinal lymph nodes compared to conventional needle aspiration. A convex probe EBUS scope is used to identify the target lymph node, and Doppler mode is employed to map vascular structures for safe puncture path planning. A dedicated puncture dilation catheter is inserted under real-time EBUS guidance to puncture the airway wal
• Процедура EBUS-TBNA
  EBUS-TBNA is a standard minimally invasive bronchoscopic procedure performed under moderate sedation or general anesthesia to obtain cytological samples from mediastinal lymph nodes. A convex probe EBUS scope is used to identify the target lymph node, and Doppler mode is employed to map vascular structures for safe puncture path planning. A dedicated 22G EBUS aspiration needle is inserted under real-time ultrasound guidance to puncture the airway wall and enter the target lymph node. Standard "t

Первичные конечные точки

• Granuloma Detection Rate [Срок оценки: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)]

Вторичные конечные точки (4)

• Mycobacterium tuberculosis Culture Positivity Rate [Срок оценки: Up to 6 weeks post-procedure (standard mycobacterial culture reporting time)]
• Acid-Fast Bacilli (AFB) Smear Positivity Rate [Срок оценки: Within 1 week post-procedure]
• Xpert MTB/RIF Ultra Positivity Rate [Срок оценки: Within 3 days post-procedure]
• Procedure-Related Complication Rate [Срок оценки: From start of procedure through 7 days post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• 2nd Yinghuadong Street, Beijing, China — Пекин

Идентификаторы

NCT: NCT07459569 · DETECTION-LYM-TB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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