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Clinical Trial Summary

In the last few years, high-definition (HD) videobronchoscopy has become widely available in the market and will progressively become the standard of care for airway inspection and sampling, as it provides substantially higher resolution images as compared to conventional white light bronchoscopy. Furthermore, in combination with improved video processor units, some HD videobronchoscopes offer post-processing real-time image enhancement (i-scan technology). Preliminary studies, performed in the setting of lung cancer, suggest that HD bronchoscopy with optical image enhancement (OE) may result in better detection of subtle vascular abnormalities in the airways, which are often associated with preneoplastic lesions. We hypothesize that HD videobronchoscopy could help identify bronchial involvement from sarcoidosis before it is (plainly) visible by conventional bronchoscopy.


Clinical Trial Description

Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that can be more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. As the thorax (bronchi, lung parenchyma, and/or intrathoracic lymph nodes) is almost invariably involved, bronchoscopy with its ancillary sampling procedures (endobronchial biopsy, transbronchial lung biopsy, bronchoalveolar lavage, conventional and ultrasound guided-transbronchial needle aspiration, endoscopic ultrasound with fine needle aspiration) has been the diagnostic tool most frequently used to confirm pathologically the clinical suspect of sarcoidosis. Among the possible bronchoscopic sampling procedures, endobronchial biopsy (EBB), which is the easiest and safest, has long been used, even though its value has been assessed in small studies, mostly retrospective. Although its diagnostic yield has been shown to be widely variable (5%-71%) across different studies, EBB has constantly demonstrated to increase the diagnostic success of bronchoscopy in sarcoidosis when coupled with other sampling methods. In the last few years, high-definition (HD) videobronchoscopy has become widely available in the market and will progressively become the standard of care for airway inspection and sampling, as it provides substantially higher resolution images as compared to conventional white light bronchoscopy. Furthermore, in combination with improved video processor units, some HD videobronchoscopes offer post-processing real-time image enhancement (i-scan technology). Preliminary studies, performed in the setting of lung cancer, suggest that HD bronchoscopy with optical image enhancement (OE) may result in better detection of subtle vascular abnormalities in the airways, which are often associated with preneoplastic lesions. We hypothesize that HD videobronchoscopy could help identify bronchial involvement from sarcoidosis before it is (plainly) visible by conventional bronchoscopy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04743596
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Completed
Phase
Start date March 17, 2021
Completion date September 30, 2022

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