High-definition Videobronchoscopy in Sarcoidosis

Study Overview
=================
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.

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

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Device: High-Definition Videobronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication to a pathological confirmation of the clinical and radiological (CT) suspect of sarcoidosis; age > 18 years; ASA score 1-3. Exclusion Criteria: inability to consent; steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy; pregnancy; uncontrolled coagulopathy; contraindication to temporary interruption of anticoagulants or antiplatelet drugs, except aspirin;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcoidosis group<br>Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician. | Device: High-Definition Videobronchoscopy<br>* Endoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |