NCT06701448

Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions

Comparative Performance of Robotic, Electromagnetic Navigation and Fluoroscopy Drives Optimal Diagnostic Strategy for Peripheral Pulmonary Lesions: a Prospective, Multi-center, Parallel-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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. The Unicorn Kylin™ robotic system represents a novel Robotic Bronchoscopy System (RBS). The system comprises an unit with two mechanical arms boasting nine degrees of freedom, a flexible bronchoscope (outer diameter: 4.3 mm; Working channel: 2.0 mm), and a console equipped with electromagnetic navigation system. In the clinical setting, different sampling methods have a crucial impact on the quality of tissue samples and the treatment of patients. However, there are currently no existing studies that directly compare the diagnostic performance of RBS, ENB, and FB using the same definition of diagnostic yield in a homogenous patient population. It is imperative to gather comparative effectiveness data on these systems in order to develop an optimal strategy for patient care. Therefore, this study aimed to assess the diagnostic performance of RBS, ENB, and FB when conducting peripheral pulmonary biopsies. To achieve this goal, a multicenter controlled study was conducted across six medical centers or hospitals.

Conditions

• Pulmonary Nodule
• Bronchoscopy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	robotic bronchosopy	robotic bronchoscopy
DIAGNOSTIC_TEST	Electromagnetic Navigation Bronchoscopy	Electromagnetic Navigation Bronchoscopy
DIAGNOSTIC_TEST	Fluoroscopy bronchoscopy	Fluoroscopy bronchoscopy

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-11-22
• Last updated: 2024-11-25

Locations

1 site across 1 country: China