Sarcoidosis, PulmonaryNABSNCT05311150
An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis
A study testing Narrow band imaging bronchoscopy guided endobronchial biopsy and White light bronchscopy guided endobronchial biopsy in people with Sarcoidosis, Pulmonary, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
In the diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (NBI) bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Narrow band imaging bronchoscopy guided endobronchial biopsy and White light bronchscopy guided endobronchial biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2022to 15 Feb 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years.
- Clinical presentation and radiological findings (enlarged hilar and or mediastinal lymph nodes >10 mm [short axis], and/or perilymphatic nodules or peribronchovascular thickening on computed tomography [CT] chest) suggesting sarcoidosis.
- Willing to give informed consent.
Who cannot join
- Hemodynamic instability (systolic BP <100 mm Hg).
- Pregnancy.
- Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
About this study
Official title: A Randomized Control Trial to Compare the Diagnostic Yield of Endobronchial Biopsy Performed Under Direct Narrow Band Imaging or White Light Bronchoscopy Guidance in Suspected Sarcoidosis
In the diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (NBI) bronchoscopy. The present study aims to compare the diagnostic yield of endobronchial biopsyperformed under direct narrow band imaging or white light bronchoscopy guidance in suspected sarcoidosis.We hypothesize that the use of NBI will improve the yield of endobronchial biopsy in patients with sarcoidosis.
Read the detailed description
The present study will be a randomized controlled trial. It will be performed in the Bronchoscopy suite of the Department of Pulmonary Medicine, PGIMER. Subjects meeting the selection criteria will be randomized 1:1 to undergo EBB under real-time visualization with NBI or white light bronchoscopy. The randomization sequence will be computer generated and the study group allocations will be placed in opaque sealed envelopes. They will be opened just before the performance of the bronchoscopic procedures.
Primary outcome:the diagnostic yield of EBB (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)
Secondary outcomes:
- Complications related to the procedure (bleeding)
- Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Narrow band imaging bronchoscopy guided endobronchial biopsy, White light bronchscopy guided endobronchial biopsy
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band imaging bronchoscopy guided endobronchial biopsyDevice
Examination of the airways will be performed with the narrow band imaging mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.
White light bronchscopy guided endobronchial biopsyDevice
Examination of the airways will be performed with the white light bronchoscopy mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator.
| Study group | Role | What they receive |
|---|---|---|
| Narrow band imaging bronchoscopy | Active comparator | The narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm. Receives: Device: Narrow band imaging bronchoscopy guided endobronchial biopsy |
| White light bronchoscopy | Active comparator | The white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm. Receives: Device: White light bronchscopy guided endobronchial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis
Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)
Measured: 7 days
Secondary outcomes (2)
Complications: Bleeding
The incidence of bleeding after the endobronchial biopsy
Measured: 1 day
Procedure duration
Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Jan 2023
- Study completion15 Feb 2023
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 Sarcoidosis, PulmonaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahajal Dhooria, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ashutosh N Aggarwal, MD, DM, Study chair, PGIMER, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311150
- Sponsor's protocol ID
- INT/IEC/2021/SPL-1817
- Acronym
- NABS
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rathi K, Dogra P, Agarwal R, Singh Sehgal I, Muthu V, Thurai Prasad K, Aggarwal AN, Bal A, Gupta N, Dhooria S. A randomized trial of narrow band imaging for performing airway mucosal biopsy in pulmonary sarcoidosis (NABS). Sarcoidosis Vasc Diffuse Lung Dis. 2025 Sep 30;42(3):16418. doi: 10.36141/svdld.v42i3.16418.
PubMed 41026031
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Compare the Diagnostic Yield of Endobronchial Biopsy Performed Under Direct Narrow Band Imaging or White Light Bronchoscopy Guidance in Suspected Sarcoidosis
- ClinicalTrials.gov ID
- NCT05311150
- Acronym / sponsor ID
- NABS / INT/IEC/2021/SPL-1817
- Conditions
- Sarcoidosis, Pulmonary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 5 Apr 2022 (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 diagnosis of patients with sarcoidosis, there is paucity of literature on the diagnostic yield of the endobronchial biopsies obtained with narrow band imaging (NBI) bronchoscopy. The present study aims to compare the diagnostic yield of endobronchial biopsyperformed under direct narrow band imaging or white light bronchoscopy guidance in suspected sarcoidosis.We hypothesize that the use of NBI will improve the yield of endobronchial biopsy in patients with sarcoidosis.
Detailed description
The present study will be a randomized controlled trial. It will be performed in the Bronchoscopy suite of the Department of Pulmonary Medicine, PGIMER. Subjects meeting the selection criteria will be randomized 1:1 to undergo EBB under real-time visualization with NBI or white light bronchoscopy. The randomization sequence will be computer generated and the study group allocations will be placed in opaque sealed envelopes. They will be opened just before the performance of the bronchoscopic procedures.
Primary outcome:the diagnostic yield of EBB (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)
Secondary outcomes:
- Complications related to the procedure (bleeding)
- Duration of procedure (from the time of entry into the trachea till the completion of the endobronchial biopsy)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow band imaging bronchoscopy | Active comparator | Device: Narrow band imaging bronchoscopy guided endobronchial biopsyThe narrow band imaging mode uses two narrow bands of light with wavelengths of 390-445 nm and 530-550 nm. |
| White light bronchoscopy | Active comparator | Device: White light bronchscopy guided endobronchial biopsyThe white light bronchoscopy mode uses the entire range of white light wavelengths, 400-700 nm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18 years.
- Clinical presentation and radiological findings (enlarged hilar and or mediastinal lymph nodes >10 mm [short axis], and/or perilymphatic nodules or peribronchovascular thickening on computed tomography [CT] chest) suggesting sarcoidosis.
- Willing to give informed consent.
Key exclusion criteria (4 listed)
- Hemodynamic instability (systolic BP <100 mm Hg).
- Pregnancy.
- Treatment with systemic glucocorticoids for more than three weeks in the preceding three months.
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy.
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 |
|---|---|---|
| Narrow band imaging bronchoscopy guided endobronchial biopsyExamination of the airways will be performed with the narrow band imaging mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator. | Device | Narrow band imaging bronchoscopy |
| White light bronchscopy guided endobronchial biopsyExamination of the airways will be performed with the white light bronchoscopy mode using a flexible video-bronchoscope (BF-1T 180, Olympus Medical, Japan). Endobronchial biopsies will be performed from the abnormal areas as deemed by the operator. | Device | White light bronchoscopy |
Primary outcome
Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis
Time frame: 7 days
Diagnostic yield of endobronchial biopsy (demonstration of granulomatous inflammation in EBB specimen, in subjects with a final diagnosis of sarcoidosis)
2 secondary outcomes
Complications: Bleeding
Time frame: 1 day
Procedure duration
Time frame: 1 day
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 29 Mar 2023.
- Derived from this study: PubMed 41026031Rathi K, Dogra P, Agarwal R, Singh Sehgal I, Muthu V, Thurai Prasad K, Aggarwal AN, Bal A, Gupta N, Dhooria S. A randomized trial of narrow band imaging for performing airway mucosal biopsy in pulmonary sarcoidosis (NABS). Sarcoidosis Vasc Diffuse Lung Dis. 2025 Sep 30;42(3):16418. doi: 10.36141/svdld.v42i3.16418.
- 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.
Ashutosh N Aggarwal, MD, DM study chair
PGIMER, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band imaging bronchoscopy guided endobronchial biopsy and White light bronchscopy guided endobronchial biopsy in people with Sarcoidosis, Pulmonary, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Yield of granulomatous inflammation in endobronchial biopsy in subjects with a final diagnosis of sarcoidosis (time frame: 7 days). 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 NCT05311150, 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 29 Mar 2023.