An Exploratory Clinical Trial on the Integration of Detection, Sampling and Treatment of Peripheral Lung Cancer by Robotic Bronchoscopy System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Integrated completion rate of detection, sampling and treatment
研究概览
简要总结
Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female.
- •High-risk pulmonary nodule/tumor maximum diameter ≤3 cm.
- •Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.
- •Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.
排除标准
- •Diffuse bilateral lung lesions unresponsive to ablation.
- •Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy.
- •Severe bleeding tendency or irreversible coagulopathy (PT >18 s, PTA <40%).Platelet count <70×10⁹/L; anticoagulant/antiplatelet therapy discontinued <1 week before ablation (except prophylactic low-molecular-weight heparin).
- •Severe pulmonary impairment (maximal voluntary ventilation <40%).
- •Other metastatic tumors with widespread metastasis; life expectancy <3 months.
- •Poor general condition: widespread metastasis, severe infection, high fever, infectious/radiation inflammation around the lesion, obvious cachexia, severe organ dysfunction, severe anemia, uncorrectable metabolic/nutritional disorders.
- •Eastern Cooperative Oncology Group (ECOG) performance status >
- •Target lesion received radiotherapy within the past 6 months.
- •Active hepatitis B, active hepatitis C, known HIV-1/2 antibody positivity, or other active infections judged by the investigator to interfere with treatment.
- •History of epilepsy, psychosis, or cognitive impairment.
- •Pregnant/lactating females; males or females planning conception during the trial.
- •Other conditions deemed inappropriate by the investigator.
研究组 & 干预措施
One-stop group
Using RBS, nCLE, r-EBUS, OBCT and ablation
干预措施: Ablation (Procedure)
结局指标
主要结局
Integrated completion rate of detection, sampling and treatment
时间窗: Day 1 (when the procedure was completed and a CBCT scan was conducted to determine the ablation range)
Integrated completion rate of detection, sampling and treatment= (Number of cases with successful integrated detection, sampling and treatment / Total enrolled cases) × 100% Definition of integrated success: Under the guidance of the bronchial navigation and positioning system, the lesion is confirmed by radial endobronchial ultrasound (r-EBUS) or CBCT; imaging diagnosis is obtained via probe-based confocal laser endomicroscopy (pCLE); qualified tissue samples are successfully collected; and local treatment is completed.
次要结局
- Diagnostic success rate(3 days after procedure( when the pathological examination results are available))
研究者
Li Shiyue
Professor
Guangzhou Medical University