Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) for Diagnosis of Peripheral Pulmonary Nodules: A Prospective Cohort Study in Korea (the ULSAN-ION Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic Yield (Proportion of lesions with definitive diagnosis)
研究概览
简要总结
What is this study about? This study tests a new robotic technology to take tissue samples from lung nodules (small spots in the lungs). Some lung nodules are cancer, but doctors need a tissue sample to know for sure.
What is the problem? Current methods to get tissue from lung nodules only work about 7 out of 10 times. When they don't work, doctors may need riskier procedures.
What is the new technology? The new technology is called robotic bronchoscopy (ssRAB). It uses a robot with special sensors to guide a thin tube more accurately to lung nodules than current methods.
Who can join? Adults aged 19 or older who have lung nodules that need tissue sampling and are healthy enough for the procedure.
What happens? Participants will have the robotic procedure while asleep under anesthesia. The robot guides a thin tube to the lung nodule to take a small tissue sample. Participants are watched for problems and followed for 6 months.
What are the risks and benefits? The new technology may be more accurate and safer than current methods. The main risks are small chance of lung collapse or bleeding, similar to regular procedures.
Why is this important? This study will show if the new robotic technology works well and is safe in Korea. If successful, it could help diagnose lung cancer earlier and more accurately.
This study will include 100 people at Ulsan University Hospital in Korea.
详细描述
Background and Rationale:
Peripheral pulmonary nodules (PPNs) are increasingly detected due to widespread use of computed tomography (CT) imaging and lung cancer screening programs. Current bronchoscopic diagnostic methods, including electromagnetic navigation bronchoscopy (ENB) and radial endobronchial ultrasound (rEBUS), have diagnostic yields of approximately 70%, with lower success rates for smaller nodules (<20mm), nodules in the outer third of the lung, and those without bronchus sign.
The ION endoluminal system (Intuitive Surgical, Sunnyvale, CA) represents a novel approach using shape-sensing robotic-assisted bronchoscopy (ssRAB) technology. This system employs shape-sensing fiber optics throughout the catheter length to provide real-time catheter position and orientation monitoring, enabling precise navigation and stable positioning capabilities. International studies have reported diagnostic yields of 87-90% with favorable safety profiles.
Study Design and Methodology:
This is a prospective, single-center, observational cohort study designed to evaluate the diagnostic performance and safety of ssRAB in Korean patients. The study will be conducted as part of routine clinical care, with ssRAB replacing conventional bronchoscopy for eligible patients requiring histological diagnosis of peripheral lung nodules.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Solid or part-solid peripheral pulmonary nodules confirmed on chest computed tomography (CT)
- •Patients requiring histological diagnosis as determined by the treating physician
- •Patients eligible for bronchoscopy procedure
- •Ability to provide written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or equivalent functional status allowing procedure under sedation or general anesthesia
排除标准
- •Pure ground glass opacity nodules
- •Bleeding tendency defined as platelet count less than 50,000/μL or International Normalized Ratio (INR) greater than 1.5
- •Severe cardiopulmonary dysfunction precluding deep sedation or general anesthesia
- •Pregnant or breastfeeding women
- •Life expectancy less than 6 months as assessed by the treating physician
- •Inability or unwillingness to provide informed consent
- •Absolute contraindication to bronchoscopy including:
- •Severe hypoxemia (oxygen saturation <90% on room air)
- •Severe pulmonary hypertension
- •Recent myocardial infarction (within 6 weeks)
- •Unstable angina
- •Malignant arrhythmias
- •Participation in another interventional clinical trial that may interfere with study procedures or outcomes
研究组 & 干预措施
ssRAB Cohort
Patients with peripheral lung nodules who undergo shape-sensing robotic-assisted bronchoscopy (ssRAB) for tissue sampling and diagnosis. All participants receive the same procedure using the ION endoluminal system to navigate to peripheral lung nodules and obtain tissue samples for histological diagnosis.
干预措施: Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) (Device)
结局指标
主要结局
Diagnostic Yield (Proportion of lesions with definitive diagnosis)
时间窗: At time of procedure and 6 months follow-up
The proportion of lesions with definitive diagnosis among total biopsied lesions using shape-sensing robotic-assisted bronchoscopy (ssRAB). Diagnostic results are defined as malignant findings, specific benign findings (e.g., tuberculosis, hamartoma), or non-specific benign findings confirmed by additional procedures or 6-month follow-up imaging showing nodule improvement or resolution.
次要结局
- Navigation Success Rate(At time of procedure (Day 0))
- Radial EBUS Confirmation Rate(At time of procedure (Day 0))
- Sensitivity for Malignant Nodules(6 months follow-up)
- Incidence of Procedure-related Complications(24 hours post-procedure)
- Tissue Sample Adequacy (Proportion of procedures yielding adequate tissue samples)(Within 1 week post-procedure)
- Proportion of procedures with adequate Rapid On-Site Evaluation (ROSE) Results(At time of procedure (Day 0))