SarcoidosisNCT04743596
High-definition Videobronchoscopy in Sarcoidosis
An observational study of Sarcoidosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- High-Definition Videobronchoscopy
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Mar 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician
Who may be able to join
- indication to a pathological confirmation of the clinical and radiological (CT) suspect of sarcoidosis;
- age > 18 years;
- ASA score 1-3.
Who cannot join
- 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;
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy2 sites
Azienda Ospedaliero Universitaria di Bologna
Bologna
Fondazione Policlinico Univeristario A. Gemelli IRCCS
Roma, 00168
Russia2 sites
Central TB Research Institute
Moscow
Research Institute of TB and Thoracic Surgery
Saint Petersburg
About this study
Official title: High-definition Videobronchoscopy With Optical Enhancement for the Diagnosis of Endobronchial Sarcoidosis: a Pilot Study
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.
Read the 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.
- Conditions
- Sarcoidosis
- Being tested
- High-Definition Videobronchoscopy
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Definition VideobronchoscopyDevice
Endoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis group | Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician. Receives: Device: High-Definition Videobronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (5)
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)
Measured: 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".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start17 Mar 2021
- Primary completion31 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocco Trisolini, MD, Principal investigator, Catholic University of the Sacred Hearth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743596
- Sponsor's protocol ID
- 3871
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Livi V, Sivokozov I, Annema JT, Candoli P, Vasilev I, Kramer T, Ferrari M, Madan K, Fielding D, Murgu S, Cancellieri A, Semyonova LA, Puci M, Sotgiu G, Trisolini R. High-Definition Videobronchoscopy for the Diagnosis of Airway Involvement in Sarcoidosis: The Enhance Sarcoidosis Multicenter Study. Chest. 2023 Nov;164(5):1243-1252. doi: 10.1016/j.chest.2023.04.034. Epub 2023 Apr 28.
PubMed 37121391
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-definition Videobronchoscopy With Optical Enhancement for the Diagnosis of Endobronchial Sarcoidosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT04743596
- Acronym / sponsor ID
- 3871
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis group | – | Device: High-Definition VideobronchoscopyConsecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with clinical and radiological (CT scan) suspect of sarcoidosis as assessed by a respiratory physician
Key inclusion criteria (3 listed)
- indication to a pathological confirmation of the clinical and radiological (CT) suspect of sarcoidosis;
- age > 18 years;
- ASA score 1-3.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Definition VideobronchoscopyEndoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy. | Device | Sarcoidosis group |
Primary outcome
Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the detection of granulomas
Time frame: 1 month
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)
5 secondary outcomes
Prevalence of airway abnormalities in patients with suspected sarcoidosis at HD bronchoscopy
Time frame: 1 day
Prevalence of different patterns of airway abnormalities in patients with suspected sarcoidosis at HD videobronchoscopy
Time frame: 1 day
Specificity for the detection of granulomas of the above 6 different patterns of airway abnormalities identified during HD bronchoscopy
Time frame: 1 month
The interobserver agreement for the identification of the above 6 predefined patterns of airway abnormalities.
Time frame: 1 month
Diagnostic yield for the detection of endobronchial granulomas according to clinical, radiological and endoscopic findings.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 37121391Livi V, Sivokozov I, Annema JT, Candoli P, Vasilev I, Kramer T, Ferrari M, Madan K, Fielding D, Murgu S, Cancellieri A, Semyonova LA, Puci M, Sotgiu G, Trisolini R. High-Definition Videobronchoscopy for the Diagnosis of Airway Involvement in Sarcoidosis: The Enhance Sarcoidosis Multicenter Study. Chest. 2023 Nov;164(5):1243-1252. doi: 10.1016/j.chest.2023.04.034. Epub 2023 Apr 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Trisolini, MD principal investigator
Catholic University of the Sacred Hearth
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Russia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of endobronchial biopsy guided by HD videobronchoscopy for the detection of granulomas (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.