Sarcoidosis LungCREBSNCT06853834
Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis
A study testing Cryobiopsy with liquid nitrogen and Endobronchial Forceps Biopsy in people with Sarcoidosis Lung and Pulmonary Sarcoidosis, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial summary
Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in > 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis Lung, Pulmonary Sarcoidosis
- What is being tested?
- Cryobiopsy with liquid nitrogen and Endobronchial Forceps 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 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients of suspected pulmonary sarcoidosis scheduled for routine EBUS-TBNA
Who cannot join
- Patient age less than 18 years
- Patients with co-morbid conditions like Diabetes mellitus, renal failure, chronic liver disease or any other chronic disease.
- Patients already on treatment with steroids or h/o steroids intake in last three months or on disease modifying and immunosuppressive drugs.
- Final Diagnosis other than sarcoidosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
Alok Nath, MBBS, MD, DM, +918004904532, draloknath@gmail.com
Yash Jagdhari, MBBS, MD
About this study
Official title: Prospective Randomized Controlled Study Comparing Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Suspected Sarcoidosis
Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in > 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Airway involvement, as judged by clinical features, physiologic testing, imaging techniques, bronchoscopy, and airway mucosal biopsy, has been observed in nearly two-thirds of patients with sarcoidosis. Although sarcoidosis involving thoracic lymph nodes and pulmonary parenchyma is familiar to most clinicians, airway involvement is often overlooked. The frequency of airway involvement increases as the parenchymal disease progresses, and\airway involvement is associated with increased morbidity, respiratory symptoms, and mortality. The initial airway abnormality is the inflammation manifested by mucosal edema, erythema, and the formation of granulomas. As the airway disease progresses, the mucosa may demonstrate granularity, nodularity, cobble stoning, and friability. Sarcoid granulomas tend to develop along the bronchovascular bundle or in the vicinity of the airways. Overall quality of the endobronchial biopsy (EBB) will depend on the method by which it is obtained and cryo-EBB will most likely to provide better tissue for the diagnosis in comparison to forceps biopsy which has smaller sample as well as crush artifacts. Therefore, it is hypothesized that cryo-EBB will be better than forceps EBB and combined together it will increase the overall diagnostic yield of the sarcoidosis when combined with lymph node sampling by endobronchial ultrasound guided trans-bronchial needle aspiration (EBUS-TBNA).
- Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
- Secondary Objective: To evaluate the overall diagnostic yield of combined endobronchial biopsy and EBUS-TBNA in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
Read more
The relevance and the expected outcome of the proposed study
- The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps
- The study will also provide information regarding overall increase in diagnostic yield if any when the endobronchial biopsies are combined with EBUS-TBNA.
Read the detailed description
The study will consist of consecutive patients undergoing routine EBUS-TBNA for suspected sarcoidosis AND subsequently confirmed on clinical, radiology and non-caseating granuloma on histopathology. .
150 patients will be randomized into either cryo-EBB or forceps biopsy from a computer-generated randomized table. 75 patients will be included in each arm.
Determination of the sample size was based on the primary outcome of the proportion of diagnostic yield between two independent groups. Using the z test of proportion for two independent samples to detect a one-sided target difference between the groups of 15% with 85% power and a level of significance of 5%, each group required 69 participants. With an expected attrition rate of 8-10%, we capped the total number of participants in each arm of the study at 75.
Subsequent to EBUS-TBNA, video bronchoscopy will be performed to obtain the endobronchial biopsy by using either forceps or cryo-proble. Three endobronchial biopsies from primary carina and both left and right secondary carina will be taken in each patients irrespective of the endobronchial abnormality. Additional biopsies will be taken from any endobronchial abnormality detected during the examination.
The biopsy samples will be fixed in neutral 10% buffered formalin. In the pathology laboratory the sample will be embedded in paraffin followed by staining with hematoxylin and eosin or special stain according to the requirement to allow an exact classification. The samples will be analyzed and assessed by one pathologist according to common standards describing adequacy of the sample, crush artifacts, specific diagnosis. The pathologist will be blinded from the biopsy technique that has been used.
Diagnostic yield will be defined by the ability to make an adequate diagnosis on histopathological examination of the sampled tissue. Diagnostic yield will be calculated for each biopsy technique as the number of diagnostic procedures divided by number of non-diagnostic procedures plus the number of diagnostic procedures.
- Conditions
- Sarcoidosis Lung, Pulmonary Sarcoidosis
- Being tested
- Cryobiopsy with liquid nitrogen, Endobronchial Forceps Biopsy
- Keywords
- Forceps Endobronchial Biopsy, Cryo-Endobronchial Biopsy, Pulmonary Sarcoidosis, Diagnostic yield of endobronchial biopsy in sarcoidosis
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryobiopsy with liquid nitrogenDevice
Also called Forceps biopsy, Cryo Biopsy
Forceps vs Cryo Endobronchial Biopsy
Endobronchial Forceps BiopsyDevice
Also called Cryo Biopsy, Forcpes Biopsy
Comparision of forceps and cryo endobronchial biopsy
| Study group | Role | What they receive |
|---|---|---|
| Cryo-Endobronchial Biopsy | Experimental | Endobronchial biopsy obtained using CRYO-Probe Receives: Device: Cryobiopsy with liquid nitrogen |
| Forceps Endobronchial Biopsy | Active comparator | Endobronchial Biopsy using Standard Bronchoscopic Biopsy Forceps Receives: Device: Endobronchial Forceps Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
To compare the diagnostic yield of cryo-endobronchial biopsy with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
Measured: Two week after the end of enrollment
Secondary outcomes (3)
Over all diagnostic yield
Overall diagnostic yield - TBNA + Endobronchial Biopsy
Measured: Two week after the end of enrollment
Complications
Complications of endobronchial biopsy
Measured: From enrollment to Two week after the end of enrollment
Dignostic yield based on endobronchial abnormality
Diagnostic yield in normal vs abnormal endobronchial fingins
Measured: Two week after the end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Jan 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis LungStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ajmal Khan, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Ajmal Khan, MBBS, MD, DM, Principal investigator, SGPGIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853834
- Sponsor's protocol ID
- DMEBBRCT001
- Acronym
- CREBS
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available on request to principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study Comparing Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Suspected Sarcoidosis
- ClinicalTrials.gov ID
- NCT06853834
- Acronym / sponsor ID
- CREBS / DMEBBRCT001
- Conditions
- Sarcoidosis Lung, Pulmonary Sarcoidosis
- Keywords
- Forceps Endobronchial Biopsy, Cryo-Endobronchial Biopsy, Pulmonary Sarcoidosis, Diagnostic yield of endobronchial biopsy in sarcoidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in > 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Airway involvement, as judged by clinical features, physiologic testing, imaging techniques, bronchoscopy, and airway mucosal biopsy, has been observed in nearly two-thirds of patients with sarcoidosis. Although sarcoidosis involving thoracic lymph nodes and pulmonary parenchyma is familiar to most clinicians, airway involvement is often overlooked. The frequency of airway involvement increases as the parenchymal disease progresses, and\airway involvement is associated with increased morbidity, respiratory symptoms, and mortality. The initial airway abnormality is the inflammation manifested by mucosal edema, erythema, and the formation of granulomas. As the airway disease progresses, the mucosa may demonstrate granularity, nodularity, cobble stoning, and friability. Sarcoid granulomas tend to develop along the bronchovascular bundle or in the vicinity of the airways. Overall quality of the endobronchial biopsy (EBB) will depend on the method by which it is obtained and cryo-EBB will most likely to provide better tissue for the diagnosis in comparison to forceps biopsy which has smaller sample as well as crush artifacts. Therefore, it is hypothesized that cryo-EBB will be better than forceps EBB and combined together it will increase the overall diagnostic yield of the sarcoidosis when combined with lymph node sampling by endobronchial ultrasound guided trans-bronchial needle aspiration (EBUS-TBNA).
- Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
- Secondary Objective: To evaluate the overall diagnostic yield of combined endobronchial biopsy and EBUS-TBNA in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
The relevance and the expected outcome of the proposed study
- The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps
- The study will also provide information regarding overall increase in diagnostic yield if any when the endobronchial biopsies are combined with EBUS-TBNA.
Detailed description
The study will consist of consecutive patients undergoing routine EBUS-TBNA for suspected sarcoidosis AND subsequently confirmed on clinical, radiology and non-caseating granuloma on histopathology. .
150 patients will be randomized into either cryo-EBB or forceps biopsy from a computer-generated randomized table. 75 patients will be included in each arm.
Determination of the sample size was based on the primary outcome of the proportion of diagnostic yield between two independent groups. Using the z test of proportion for two independent samples to detect a one-sided target difference between the groups of 15% with 85% power and a level of significance of 5%, each group required 69 participants. With an expected attrition rate of 8-10%, we capped the total number of participants in each arm of the study at 75.
Subsequent to EBUS-TBNA, video bronchoscopy will be performed to obtain the endobronchial biopsy by using either forceps or cryo-proble. Three endobronchial biopsies from primary carina and both left and right secondary carina will be taken in each patients irrespective of the endobronchial abnormality. Additional biopsies will be taken from any endobronchial abnormality detected during the examination.
The biopsy samples will be fixed in neutral 10% buffered formalin. In the pathology laboratory the sample will be embedded in paraffin followed by staining with hematoxylin and eosin or special stain according to the requirement to allow an exact classification. The samples will be analyzed and assessed by one pathologist according to common standards describing adequacy of the sample, crush artifacts, specific diagnosis. The pathologist will be blinded from the biopsy technique that has been used.
Diagnostic yield will be defined by the ability to make an adequate diagnosis on histopathological examination of the sampled tissue. Diagnostic yield will be calculated for each biopsy technique as the number of diagnostic procedures divided by number of non-diagnostic procedures plus the number of diagnostic procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo-Endobronchial Biopsy | Experimental | Device: Cryobiopsy with liquid nitrogenEndobronchial biopsy obtained using CRYO-Probe |
| Forceps Endobronchial Biopsy | Active comparator | Device: Endobronchial Forceps BiopsyEndobronchial Biopsy using Standard Bronchoscopic Biopsy Forceps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of suspected pulmonary sarcoidosis scheduled for routine EBUS-TBNA
Key exclusion criteria (4 listed)
- Patient age less than 18 years
- Patients with co-morbid conditions like Diabetes mellitus, renal failure, chronic liver disease or any other chronic disease.
- Patients already on treatment with steroids or h/o steroids intake in last three months or on disease modifying and immunosuppressive drugs.
- Final Diagnosis other than sarcoidosis
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 |
|---|---|---|
| Cryobiopsy with liquid nitrogenAlso: Forceps biopsy, Cryo BiopsyForceps vs Cryo Endobronchial Biopsy | Device | Cryo-Endobronchial Biopsy |
| Endobronchial Forceps BiopsyAlso: Cryo Biopsy, Forcpes BiopsyComparision of forceps and cryo endobronchial biopsy | Device | Forceps Endobronchial Biopsy |
Primary outcome
Diagnostic Yield
Time frame: Two week after the end of enrollment
To compare the diagnostic yield of cryo-endobronchial biopsy with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis.
3 secondary outcomes
Over all diagnostic yield
Time frame: Two week after the end of enrollment
Complications
Time frame: From enrollment to Two week after the end of enrollment
Dignostic yield based on endobronchial abnormality
Time frame: Two week after the end of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Undecided. Available on request to principle investigator
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An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
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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.
Ajmal Khan, MBBS, MD, DM principal investigator
SGPGIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryobiopsy with liquid nitrogen and Endobronchial Forceps Biopsy in people with Sarcoidosis Lung and Pulmonary Sarcoidosis, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences 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 1 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: looking for participants now, as of the sponsor's last update on 3 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajmal Khan, MBBS, MD, DM (+919878678689, drajmal13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: Two week after the end of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.