EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE

Официальное название

Endobronchial Ultrasound-Guided Transtunnel Forceps Biopsy vs. Transbronchial Needle Aspiration for Diagnosing Inadequate Lymph Node Specimens Based on Macroscopic On-site Evaluation: A Prospective, Randomized, Multicenter Study

Обзор

The study aims to compare the efficacy and safety of endobronchial ultrasound-guided transtunnel forceps biopsy to transbronchial needle aspiration in diagnosing inadequate lymph node specimens based on macroscopic on-site evaluation.

Подробное описание

Mediastinal and hilar lymphadenopathy are common clinical conditions. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard method recommended by guidelines for obtaining tissue from these patients. Endobronchial ultrasound-guided transbronchial forceps biopsy (EBUS-TBFB) can overcome the limitations of inadequate tissue acquisition with EBUS-TBNA, and its efficacy and safety have been proved. However, EBUS-TBFB often requires the assistance of the electrocautery for mediastinal window creation, which increases technical difficulty and requires electrosurgical equipment, making it unsuitable for application in grassroots hospitals.

This study aims to use the endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) method. A single-use bronchoscopic puncture dilation catheter will be employed to establish a tunnel between the airway and the lymph node, with both puncture and dilation completed in the same procedure. Currently, there is a lack of prospective randomized controlled trials to verify the efficacy and safety of EBUS-TTFB.

This study is designed as a prospective, multicenter, randomized controlled trial. A total of 162 patients will be randomly allocated in a 1:1 ratio to the EBUS-TBNA group or the EBUS-TTFB group. The primary endpoint is thediagnostic yield. The secondary endpoints include specimen adequacy, procedure duration, tunnel creation success rate, and safety.

Вмешательства

• Процедура EBUS-TBNA
  Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
• Процедура EBUS-TTFB
  Participants with lymphadenopathy would receive EBUS-TTFB attempts to conduct diagnoses.

Первичные конечные точки

• Diagnostic yield [Срок оценки: Six months after the procedure]

Вторичные конечные точки (6)

• Sample adequacy [Срок оценки: Six months after the procedure]
• Total procedure time [Срок оценки: During the procedure]
• TTFB procedure time [Срок оценки: During the procedure]
• TBNA procedure time [Срок оценки: During the procedure]
• Tunnel creation success rate [Срок оценки: During the procedure]
• Incidence of complications [Срок оценки: Six months after the procedure]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Chest imaging shows mediastinal or hilar lymphadenopathy (short axis ≥10 mm), requiring EBUS-TBNA for definitive diagnosis;
• EBUS-TBNA can be performed on these lymph nodes, and the specimens obtained from conventional EBUS-TBNA with three needle passes are inadequate (macroscopic visible core < 30 mm);
• Willing to participate in this clinical study and sign the informed consent form.

Критерии исключения

• Enlarged lymph nodes are identified as cystic or abscesses;
• Severe coagulopathy, insufficient anticoagulants/antiplatelets withdraw time or bleeding diathesis (platelets<50\*109/L, INR>1.3) that do not meet bronchoscopy requirements;
• Other contraindications to bronchoscopy or transbronchial biopsy, such as severe cardiopulmonary insufficiency, intolerance to anesthesia, or endoscopic procedures;
• Patients who have participated in another clinical trial within the past three months;
• Vulnerable groups, such as pregnant women
• Any other condition that the investigator considers inappropriate for participation in this study.

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

Простое слепое

Основная цель

Диагностика

Центры проведения

Китай · 3 центра

• The Fourth Affiliated Hospital of China Medical University — Шэньян
• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Huzhou Central Hospital — Huizhou

Идентификаторы

NCT: NCT06913569 · SHCHE202502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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