RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

Официальное название

Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study

Обзор

The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.

Подробное описание

This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.

Вмешательства

• Устройство Robotic bronchoscopy system
  Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
• Устройство Ultrathin bronchoscope combined with virtual bronchoscopic navigation
  Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

Первичные конечные точки

• Diagnostic yield [Срок оценки: 14 days post-procedure]

Вторичные конечные точки (4)

• Navigation success yield [Срок оценки: During the procedure]
• Navigation time [Срок оценки: During the procedure]
• Incidence of complications [Срок оценки: 14 days post-procedure]
• Strict definition of diagnostic yield [Срок оценки: 14 days post-procedure]

Критерии участия

Критерии включения

• Age ≥ 18 years, regardless of gender;
• Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
• Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
• Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Критерии исключения

• Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
• Patients with pure ground-glass nodules suspected of malignancy on chest CT;
• Female patients who are breastfeeding, pregnant, or planning pregnancy;
• Patients with electromagnetic active implantable medical devices;
• Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
• Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
• Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

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 · 5 центров

• Shandong Public Health Clinical Center — Цзинань
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Shanghai Chest Hospital — Шанхай
• Zhongshan Hospital，Fudan University — Шанхай
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06962436 · SHCHE202503

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗