Shape-Sensing Robotic-Assisted Bronchoscopy for Diagnosis of Peripheral Pulmonary Nodules in Korea

Официальное название

Shape-sensing Robotic-assisted Bronchoscopy (ssRAB) for Diagnosis of Peripheral Pulmonary Nodules: A Prospective Cohort Study in Korea (the ULSAN-ION Study)

Обзор

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.

Подробное описание

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.

Pre-procedure Planning:

All participants will undergo thin-section chest CT (≤1.25mm thickness) for 3D navigation planning using PlanPoint Planning Laptop software. Target nodule characteristics, approach pathways, and procedure strategy will be determined prior to the procedure.

Procedure Protocol:

The ssRAB procedure will be performed under deep sedation or general anesthesia using an 8.0mm or larger endotracheal tube. The procedure involves:

1. Initial airway assessment using conventional flexible bronchoscopy 2. ION system docking to the endotracheal tube 3. Vision probe insertion through the ION catheter (3.5mm outer diameter, 2mm working channel) 4. System registration to align navigation mapping with patient anatomy 5. Catheter navigation to target nodule 6. Vision probe removal and radial EBUS confirmation (when applicable) 7. Tissue sampling using various tools (Flexision biopsy needles, forceps, brush, or cryobiopsy) 8. Fluoroscopic guidance when needed 9. Rapid on-site evaluation (ROSE) when available

Safety Monitoring:

All procedure-related complications will be documented according to CTCAE v5.0 criteria. Post-procedure monitoring includes chest imaging to assess for pneumothorax and clinical observation for bleeding, infection, or other adverse events. Participants will be followed for 24 hours post-procedure for immediate complications.

Follow-up and Diagnosis Confirmation:

Participants will be followed for 6 months to establish final diagnosis. For non-specific benign findings, final diagnosis will be confirmed through additional procedures (surgery or CT-guided biopsy) or 6-month follow-up imaging showing nodule improvement or resolution.

Statistical Analysis:

The primary endpoint is diagnostic yield, defined as the proportion of lesions with definitive diagnosis among total sampled lesions. Secondary endpoints include navigation success rate, rEBUS confirmation rate, procedural performance metrics (registration time, navigation time, total procedure time, fluoroscopy time), and safety outcomes. Based on previous studies reporting 87.8% diagnostic yield, a sample size of 100 patients provides adequate power with 95% confidence interval and ±7% margin of error, accounting for 10% dropout rate.

Expected Impact:

This study will provide the first Korean data on ssRAB performance and safety, potentially establishing evidence for broader implementation of this technology in Korea. The results may contribute to improved diagnostic accuracy for peripheral lung nodules and better patient outcomes through earlier and more accurate diagnosis of lung cancer.

Вмешательства

• Устройство Shape-sensing Robotic-assisted Bronchoscopy (ssRAB)
  Diagnostic procedure using the ION endoluminal system (Intuitive Surgical, Sunnyvale, CA) for navigation and tissue sampling of peripheral pulmonary nodules. The procedure involves: 1. Pre-procedure 3D navigation planning using thin-section chest CT 2. Shape-sensing catheter navigation to target nodules 3. Real-time position monitoring with fiber optic sensors 4. Tissue sampling using various tools (biopsy needles, forceps, brush, or cryobiopsy) 5. Optional radial endobronchial ultrasound (rEBU

Первичные конечные точки

• Diagnostic Yield (Proportion of lesions with definitive diagnosis) [Срок оценки: At time of procedure and 6 months follow-up]

Вторичные конечные точки (6)

• Navigation Success Rate [Срок оценки: At time of procedure (Day 0)]
• Radial EBUS Confirmation Rate [Срок оценки: At time of procedure (Day 0)]
• Sensitivity for Malignant Nodules [Срок оценки: 6 months follow-up]
• Incidence of Procedure-related Complications [Срок оценки: 24 hours post-procedure]
• Tissue Sample Adequacy (Proportion of procedures yielding adequate tissue samples) [Срок оценки: Within 1 week post-procedure]
• Proportion of procedures with adequate Rapid On-Site Evaluation (ROSE) Results [Срок оценки: At time of procedure (Day 0)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Ulsan University Hospital — Ulsan

Публикации

• Xie F, Zhang Q, Mu C, Zhang Q, Yang H, Mao J, Simoff MJ, Huang J, Zhang X, Sun J. Shape-sensing Robotic-assisted Bronchoscopy (SS-RAB) in Sampling Peripheral Pulmonary Nodules: A Prospective, Multicenter Clinical Feasibility Study in China. J Bronchology Interv Pulmonol. 2024 Aug 8;31(4):e0981. doi: 10.1097/LBR.0000000000000981. eCollection 2024 Oct 1. PMID 39115240
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• MacMahon H, Naidich DP, Goo JM, Lee KS, Leung ANC, Mayo JR, Mehta AC, Ohno Y, Powell CA, Prokop M, Rubin GD, Schaefer-Prokop CM, Travis WD, Van Schil PE, Bankier AA. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017. Radiology. 2017 Jul;284(1):228-243. doi: 10.1148/radiol.2017161659. Epub 2017 Feb 23. PMID 28240562
• Kang MJ, Won YJ, Lee JJ, Jung KW, Kim HJ, Kong HJ, Im JS, Seo HG; Community of Population-Based Regional Cancer Registries. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2019. Cancer Res Treat. 2022 Apr;54(2):330-344. doi: 10.4143/crt.2022.128. Epub 2022 Mar 16. PMID 35313102
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Идентификаторы

NCT: NCT07057648 · 2025-06-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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