Diagnostic Value and Safety of Combined Biopsy for Mediastinal Metastasis of Lung Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: EBUS-TBMCB.
- Кому может быть актуально
- Состояния в реестре: Mediastinal Metastases of Lung Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Diagnostic Value and Safety of EBUS-TBNA Combined With Medaistinal Cryobiopsy for Mediastinal Metastasis of Lung Cancer
Обзор
The study is aimed o evaluate the diagnostic performance and treatment guidance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBUS-TBMCB) in patients with mediastinal metastases of lung cancer.
Подробное описание
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), will serve as control. Enrolled patients will be randomly assigned to two groups: the experimental group, which will undergo EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) following EBUS-TBNA, and control group, which will undergo EBUS-TBNA alone. Biopsy specimens from both groups will be analyzed by pathologists. All patients will be followed up to confirm the diagnosis and to document any complications. The diagnostic yield for lung cancer and the incidence of procedure-related adverse events will be compared between the two groups.
Вмешательства
- Процедура EBUS-TBMCB
Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA
Первичные конечные точки
- Diagnostic yield for lung cancer [Срок оценки: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months]
Вторичные конечные точки (5)
- Diagnostic accuracy [Срок оценки: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months]
- Sample size [Срок оценки: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months]
- Suitability for molecular assays [Срок оценки: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months]
- Duration of bronchoscopic procedure [Срок оценки: From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months]
- Incidence of procedure-related adverse events [Срок оценки: Within 30 days post-biopsy]
Критерии участия
Критерии включения
- Aged ≥18 years;
- Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
- Patients who have not undergone prior mediastinal biopsy and require further mediastinal biopsy to confirm etiology or pathological subtype, meeting at least one of the following criterias:
(1) suspected lung cancer diagnosed by two senior physicians; (2) confirmed lung cancer (requiring mediastinal staging); (3) recurrent lung cancer; 4.Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out contraindications; 5. Patients are informed and capable of providing written informed consent.
Критерии исключения
- Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy;
- Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts;
- Lesions identified as abscesses or cysts;
- Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent;
- Patients who have participated in other clinical trials within 3 months;
- Any other conditions considered to be inappropriate to be involved in this trial.
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 · 1 центр
- Third Military Medical University — Чунцин
Идентификаторы
NCT: NCT07488507 · 2026-Research No. 038-02