SarcoidosisNCT03656003
A Study Evaluating the Diagnostic Yield and Safety of the ProCore vs Conventional EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis
A study testing Procore biopsy needle and Conventional biopsy needle in people with Sarcoidosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study evaluates the yield and safety of two different needles for performing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis. The two needles that will be compared will be the 22-gauge ProCore needle and the conventional 22-gauge EBUS-TBNA needle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Procore biopsy needle and Conventional biopsy needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2018to 31 Jul 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients meeting all the following criteria will be eligible for inclusion in the study:
- Age group of 18 to 75 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
- Ability to provide informed consent to participate in the study
Exclusion Criteria: Patients with any of the following will be excluded:
- Hypoxemia (SpO2 <92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the yield and safety of two different needles for performing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis. The two needles that will be compared will be the 22-gauge ProCore needle and the conventional 22-gauge EBUS-TBNA needle.
Read the detailed description
Sarcoidosis is a multisystem disorder of unknown cause characterized by granulomatous inflammation involving various organ systems. The diagnosis is made on the basis of a suggestive clinicoradiological picture, histopathologic evidence of non-caseating granuloma, and exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling.
Among the bronchoscopic techniques, TBNA of lymph nodes is a useful modality especially when combined with endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA are well established. With the advent of endobronchial ultrasound (EBUS) in the last decade, this new technology has been widely used to guide transbronchial needle aspiration. The technique is minimally invasive and offers the additional advantage of choosing the appropriate node for sampling based on the vascularity, echogenicity and size. Studies subsequently have demonstrated the superiority of EBUS-TBNA over conventional TBNA.
As EBUS-TBNA is the standard procedure now for accessing intrathoracic lymph nodes, the technical aspects of the procedure need further investigation. Several aspects have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the distance travelled by the needle within the lymph node.
The EchoTip ProCore High Definition ultrasound biopsy needle (Cook Medical Inc., Bloomington, Ind., USA) is a novel needle that has been used mainly in sampling intra-abdominal lesions. It has a special bevel which allows a core biopsy along with aspiration of the lymph node material. In case of mediastinal lymph node enlargement due to malignancy, needle aspiration alone may yield sufficient material to identify malignant cells. However, in sarcoidosis, the core biopsy specimen obtained with the ProCore needle may potentially increase the identification of granulomas. The investigators hypothesize that the 22-gauge ProCore needle will have a higher yield in diagnosing intrathoracic lymphadenopathy due to sarcoidosis as compared to the conventional 22-gauge EBUS-TBNA needle. In this study, the investigators plan to evaluate the yield and safety of the 22-gauge ProCore needle as compared to the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- Procore biopsy needle, Conventional biopsy needle
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procore biopsy needleDevice
EBUS-TBNA with the EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA)
Conventional biopsy needleDevice
EBUS-TBNA with the conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan)
| Study group | Role | What they receive |
|---|---|---|
| Procore needle | Experimental | EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA) Receives: Device: Procore biopsy needle |
| Conventional needle | Active comparator | Conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan) Receives: Device: Conventional biopsy needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sarcoidosis diagnosed by EBUS-TBNA (Diagnostic yield)
The diagnostic yield is defined as the proportion of patients with a final diagnosis of sarcoidosis diagnosed by EBUS-TBNA
Measured: 6 months
Secondary outcomes (2)
Number of patients with adequate EBUS-TBNA aspirate on cytology
Defined as preponderance of lymphocytes or a definite diagnosis (sarcoidosis, tuberculosis or others) on EBUS-TBNA aspirate
Measured: 2 weeks
Incidence of adverse events related to EBUS-TBNA procedure in the two groups
Endobronchial bleeding, pneumothorax, hypoxemia, mediastinitis
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Aug 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ashutosh N Aggarwal, Study chair, Professor & Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656003
- Sponsor's protocol ID
- Int/IEC/2018/00169
- Status last verified
- Feb 2021
- First submitted
- 22 Aug 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhooria S, Sehgal IS, Prasad KT, Muthu V, Gupta N, Bal A, Ram B, Aggarwal AN, Agarwal R. Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis. Expert Rev Med Devices. 2021 Feb;18(2):211-216. doi: 10.1080/17434440.2021.1876560. Epub 2021 Jan 22.
PubMed 33435733
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Diagnostic Yield and Safety of the ProCore vs Conventional EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis
- ClinicalTrials.gov ID
- NCT03656003
- Acronym / sponsor ID
- Int/IEC/2018/00169
- Conditions
- Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 4 Sep 2018 (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.
This study evaluates the yield and safety of two different needles for performing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) in patients with sarcoidosis. The two needles that will be compared will be the 22-gauge ProCore needle and the conventional 22-gauge EBUS-TBNA needle.
Detailed description
Sarcoidosis is a multisystem disorder of unknown cause characterized by granulomatous inflammation involving various organ systems. The diagnosis is made on the basis of a suggestive clinicoradiological picture, histopathologic evidence of non-caseating granuloma, and exclusion of other known causes for granulomatous inflammation. As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling.
Among the bronchoscopic techniques, TBNA of lymph nodes is a useful modality especially when combined with endobronchial and transbronchial biopsies. The efficacy and safety of conventional TBNA are well established. With the advent of endobronchial ultrasound (EBUS) in the last decade, this new technology has been widely used to guide transbronchial needle aspiration. The technique is minimally invasive and offers the additional advantage of choosing the appropriate node for sampling based on the vascularity, echogenicity and size. Studies subsequently have demonstrated the superiority of EBUS-TBNA over conventional TBNA.
As EBUS-TBNA is the standard procedure now for accessing intrathoracic lymph nodes, the technical aspects of the procedure need further investigation. Several aspects have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, and the distance travelled by the needle within the lymph node.
The EchoTip ProCore High Definition ultrasound biopsy needle (Cook Medical Inc., Bloomington, Ind., USA) is a novel needle that has been used mainly in sampling intra-abdominal lesions. It has a special bevel which allows a core biopsy along with aspiration of the lymph node material. In case of mediastinal lymph node enlargement due to malignancy, needle aspiration alone may yield sufficient material to identify malignant cells. However, in sarcoidosis, the core biopsy specimen obtained with the ProCore needle may potentially increase the identification of granulomas. The investigators hypothesize that the 22-gauge ProCore needle will have a higher yield in diagnosing intrathoracic lymphadenopathy due to sarcoidosis as compared to the conventional 22-gauge EBUS-TBNA needle. In this study, the investigators plan to evaluate the yield and safety of the 22-gauge ProCore needle as compared to the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procore needle | Experimental | Device: Procore biopsy needleEchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA) |
| Conventional needle | Active comparator | Device: Conventional biopsy needleConventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Procore biopsy needleEBUS-TBNA with the EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA) | Device | Procore needle |
| Conventional biopsy needleEBUS-TBNA with the conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan) | Device | Conventional needle |
Primary outcome
Proportion of patients with sarcoidosis diagnosed by EBUS-TBNA (Diagnostic yield)
Time frame: 6 months
The diagnostic yield is defined as the proportion of patients with a final diagnosis of sarcoidosis diagnosed by EBUS-TBNA
2 secondary outcomes
Number of patients with adequate EBUS-TBNA aspirate on cytology
Time frame: 2 weeks
Incidence of adverse events related to EBUS-TBNA procedure in the two groups
Time frame: 1 week
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 23 Feb 2021.
- Derived from this study: PubMed 33435733Dhooria S, Sehgal IS, Prasad KT, Muthu V, Gupta N, Bal A, Ram B, Aggarwal AN, Agarwal R. Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis. Expert Rev Med Devices. 2021 Feb;18(2):211-216. doi: 10.1080/17434440.2021.1876560. Epub 2021 Jan 22.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
Cardiac Sarcoidosis
RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac Sarcoidosis
RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
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 study chair
Professor & Head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procore biopsy needle and Conventional biopsy needle in people with Sarcoidosis, 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?
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 23 Feb 2021. 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?
Proportion of patients with sarcoidosis diagnosed by EBUS-TBNA (Diagnostic yield) (time frame: 6 months). 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 NCT03656003, 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 23 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.