Clinical trial NCT04743596: High-definition Videobronchoscopy in Sarcoidosis
Official title: High-definition Videobronchoscopy With Optical Enhancement for the Diagnosis of Endobronchial Sarcoidosis: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. indication to a pathological confirmation of the clinical and radiological (CT) suspect of sarcoidosis;
2. age \> 18 years;
3. ASA score 1-3.

Exclusion Criteria:

1. inability to consent;
2. steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy;
3. pregnancy;
4. uncontrolled coagulopathy;
5. contraindication to temporary interruption of anticoagulants or antiplatelet drugs, except aspirin;

Primary outcomes:
measure: Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the detection of granulomas
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence of airway abnormalities in patients with suspected sarcoidosis at HD bronchoscopy
timeFrame: 1 day
measure: Prevalence of different patterns of airway abnormalities in patients with suspected sarcoidosis at HD videobronchoscopy
timeFrame: 1 day
measure: Specificity for the detection of granulomas of the above 6 different patterns of airway abnormalities identified during HD bronchoscopy
timeFrame: 1 month
measure: The interobserver agreement for the identification of the above 6 predefined patterns of airway abnormalities.
timeFrame: 1 month
measure: Diagnostic yield for the detection of endobronchial granulomas according to clinical, radiological and endoscopic findings.
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna
city: Roma
country: Italy
facility: Fondazione Policlinico Univeristario A. Gemelli IRCCS
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Moscow
country: Russian Federation
facility: Central TB Research Institute
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of TB and Thoracic Surgery
Study officials:
affiliation: Catholic University of the Sacred Hearth
name: Rocco Trisolini, MD
role: PRINCIPAL_INVESTIGATOR
References: