Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions: a Prospective, Multi-center, Parallel-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Overall diagnostic yield
研究概览
简要总结
Currently, the optimal method for Peripheral Pulmonary Lesions (PPL) is uncertain. We aim to compare the diagnostic yield of Robotic Bronchoscopy System (RBS), Electromagnetic Navigation Bronchoscopy (ENB), Fluoroscope-Bronchoscopy (FB).
详细描述
Pulmonary peripheral lesions (PPLs) are a prevalent medical condition and a significant contributory factor to the widespread health and social issues associated with pulmonary diseases, particularly lung cancer. In China, lung cancer has become the most common cancer in terms of new cases and deaths, with 1,060,600 new cases and 736,600 deaths recorded. Early diagnosis of PPLs is essential to prevent their progression to cancer.
Fluoroscopy bronchoscopy (FB) was previously the primary diagnostic method for PPLs. However, its limitation lies in the occurrence of adverse events, particularly pneumothorax. Furthermore, many patients are not suitable for percutaneous biopsy which has led to the exploration of alternative methods for diagnosis.
With the advancement of bronchoscopy, several innovative technologies have been proposed and developed for sampling tissues from PPLs in recent years. Electromagnetic navigation bronchoscopy (ENB) stands out as one of the most superior among them. Its integration of real-time guidance and precise maneuverability of a biopsy instrument gives it an advantage over alternative technologies.
The Robotic Bronchoscopy System (RBS) offers an excellent alternative method with enhanced flexibility and stability. The bronchoscopist is able to control the insertion and biopsy of the RBS from a console located near the patient, allowing for a more stable posture to access the distal airway compared to conventional bronchoscopy. Numerous studies have demonstrated that RBS exhibits an excellent navigation success rate and diagnosis rate. A multi-center study on the ION endoluminal platform (Intuitive Surgical, Inc.) revealed a navigation yield as high as 98.7% and a total diagnostic yield of 81.7%. Similarly, research on the Monarch RAB showed navigation yield and diagnostic yield of 96.2% and 74.1%, respectively.
The iLung Infinity system (LungHealth MedTech Ltd, Shanghai, China) is specifically designed to utilize real-time electromagnetic technology in order to localize and guide bronchoscopic tools towards the lesion on a pre-constructed three-dimensional bronchial tree.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for inclusion if they meet all of the following criteria:
- •Age ≥18 years and ≤75 years, with no gender restrictions;
- •Presence of a peripheral lung lesion on chest CT
- •Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
- •patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.
排除标准
- •Patients who meet any of the following criteria will be excluded from this study:
- •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;
- •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.
结局指标
主要结局
Overall diagnostic yield
时间窗: 1 years after biopsy
Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.
次要结局
- Strict diagnostic yield(7 days after biopsy)
研究者
Li Shiyue
Professor
Guangzhou Medical University