High-definition Videobronchoscopy in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

High-definition Videobronchoscopy With Optical Enhancement for the Diagnosis of Endobronchial Sarcoidosis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743596
• Other study ID #: 3871
• Status: Completed
• Start date: March 17, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Device:
• High-Definition Videobronchoscopy
Endoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria di Bologna	Bologna
Italy	Fondazione Policlinico Univeristario A. Gemelli IRCCS	Roma
Netherlands	Academic Medical Centre	Amsterdam
Russian Federation	Central TB Research Institute	Moscow
Russian Federation	Research Institute of TB and Thoracic Surgery	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Countries where clinical trial is conducted

Italy,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the detection of granulomas	The diagnostic yield will be calculated on a per patient basis (number of patients in whom the pathological examination of endobronchial biopsies shows non necrotizing granulomas/all the patients submitted to endobronchial biopsies)	1 month
Secondary	Prevalence of airway abnormalities in patients with suspected sarcoidosis at HD bronchoscopy	The prevalence of airway abnormalities will be calculated on a per patient basis (number of patients in whom the HD videobronchoscopy shows abnormalities in the endoscopically visible airways/all the patients submitted to HD videobronchoscopy)	1 day
Secondary	Prevalence of different patterns of airway abnormalities in patients with suspected sarcoidosis at HD videobronchoscopy	The following patterns of airway abnormalities, well described in the literature in the setting of endobronchial sarcoidosis, will be evaluated for the assessment of the present endpoint: a) cobblestoning (diffuse, coalescing nodules); b) nodularity (sparse, discrete nodules); c) thickening; d) plaque (infiltrative, raised, flat, white or yellowish areas); e) marked hyperaemia. In those cases in which airway abnormalities are detected, but they do not fall into any of the above patterns, they will be classified into a 6th pattern named "miscellanea".	1 day
Secondary	Specificity for the detection of granulomas of the above 6 different patterns of airway abnormalities identified during HD bronchoscopy	This endpoint will be calculated on a per-lesions basis (number of cases of airway abnormality referring to one the 6 predefined patterns in which the pathological examination of endobronchial biopsies shows non necrotizing granulomas/all the airway abnormalities referring to that specific predefined pattern submitted to endobronchial biopsy).	1 month
Secondary	The interobserver agreement for the identification of the above 6 predefined patterns of airway abnormalities.	At the end of the study, the videos referring to each endobronchial abnormality submitted to biopsy in each enrolling center will be independently classified by two interventional pulmonologist blinded to the clinical, radiological and pathological findings.	1 month
Secondary	Diagnostic yield for the detection of endobronchial granulomas according to clinical, radiological and endoscopic findings.	The association between the following findings and the diagnostic yield of EBBs will be assessed: sex; ethnicity; sarcoidosis stage (I-IV); presence versus absence of endobronchial abnormalities at HD bronchoscopy; pattern of airway abnormality at HD bronchoscopy.	6 months