Lymph Node DiseaseNCT03903471
22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA
A study testing 22G-ProCore Endobronchial Ultrasound Needle and 22G-Standard Endobronchial Ultrasound Needle in people with Lymph Node Disease, run by Jiayuan Sun at 1 site in China.
Trial summary
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Disease
- What is being tested?
- 22G-ProCore Endobronchial Ultrasound Needle and 22G-Standard Endobronchial Ultrasound Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2022to 8 Oct 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
- Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter > 1 cm in CT or PET-CT SUV value > 2.5).
- Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
- Inform consent signed.
Who cannot join
- Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5).
- Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
- Life expectancy less than 6 months.
- Uncooperative patients.
- Patients representing vulnerable populations (prisoners, pregnant women, etc).
- Researchers consider it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, PhD, +86-021-22200000 ext. 1511, jysun1976@163.com
About this study
Official title: Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
Read the detailed description
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.
- Conditions
- Lymph Node Disease
- Being tested
- 22G-ProCore Endobronchial Ultrasound Needle, 22G-Standard Endobronchial Ultrasound Needle
- Keywords
- ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
22G-ProCore Endobronchial Ultrasound NeedleDevice
EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
22G-Standard Endobronchial Ultrasound NeedleDevice
EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
| Study group | Role | What they receive |
|---|---|---|
| 22G-ProCore Group | Experimental | The experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle. Receives: Device: 22G-ProCore Endobronchial Ultrasound Needle |
| 22G-Standard Group | Active comparator | The control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle. Receives: Device: 22G-Standard Endobronchial Ultrasound Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of 22G-ProCore needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Measured: up to 6 months
Diagnostic yield of 22G-Standard needle
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Measured: up to 6 months
Secondary outcomes (2)
The quality of histologic specimen used by 22G-ProCore needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Measured: up to 6 months
The quality of histologic specimen used by 22G-Standard needle
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start8 Oct 2022 (estimated)
- Primary completion8 Oct 2023 (estimated)
- Study completion8 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lymph Node DiseaseStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD,PhD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903471
- Sponsor's protocol ID
- SHCHE201901
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stamatis G. Staging of lung cancer: the role of noninvasive, minimally invasive and invasive techniques. Eur Respir J. 2015 Aug;46(2):521-31. doi: 10.1183/09031936.00126714. Epub 2015 May 14.
PubMed 25976686Sun J, Zhang J, Zhao H, Shen J, Gu A, Han B. Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Thorac Cancer. 2010 May;1(1):28-34. doi: 10.1111/j.1759-7714.2010.00010.x.
PubMed 27755785Sun J, Teng J, Yang H, Li Z, Zhang J, Zhao H, Garfield DH, Han B. Endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing intrathoracic tuberculosis. Ann Thorac Surg. 2013 Dec;96(6):2021-7. doi: 10.1016/j.athoracsur.2013.07.005. Epub 2013 Sep 12.
PubMed 24035300Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12.
PubMed 25497069Yang H, Wang S, Teng J, Han B, Sun J. Utility of endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing non-specific inflammatory intrathorcacic lymphadenitis. Clin Respir J. 2018 Feb;12(2):691-698. doi: 10.1111/crj.12580. Epub 2016 Nov 23.
PubMed 27882677
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparion of 22G-ProCore and 22G-Standard Needle in Diagnosis of Lymphadenopathy Via EBUS-TBNA: A Prospective, Single-center, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03903471
- Acronym / sponsor ID
- SHCHE201901
- Conditions
- Lymph Node Disease
- Keywords
- ProCore, Mediastinal and Hilar Lymphadenopathy, EBUS-TBNA, Diagnostic Yield, Quality of Specimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Study start
- 8 Oct 2022 (estimated)
- Primary completion
- 8 Oct 2023 (estimated)
- Study completion
- 8 Oct 2023 (estimated)
- First posted
- 4 Apr 2019 (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.
The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
Detailed description
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 22G-ProCore Group | Experimental | Device: 22G-ProCore Endobronchial Ultrasound NeedleThe experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle. |
| 22G-Standard Group | Active comparator | Device: 22G-Standard Endobronchial Ultrasound NeedleThe control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter > 1 cm in CT or PET-CT SUV value > 2.5).
- Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
- Inform consent signed.
Key exclusion criteria (6 listed)
- Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count < 50000 or INR > 1.5).
- Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
- Life expectancy less than 6 months.
- Uncooperative patients.
- Patients representing vulnerable populations (prisoners, pregnant women, etc).
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 |
|---|---|---|
| 22G-ProCore Endobronchial Ultrasound NeedleEchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK | Device | 22G-ProCore Group |
| 22G-Standard Endobronchial Ultrasound NeedleEchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK | Device | 22G-Standard Group |
Primary outcome
Diagnostic yield of 22G-ProCore needle
Time frame: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Diagnostic yield of 22G-Standard needle
Time frame: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
2 secondary outcomes
The quality of histologic specimen used by 22G-ProCore needle
Time frame: up to 6 months
The quality of histologic specimen used by 22G-Standard needle
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 25976686Stamatis G. Staging of lung cancer: the role of noninvasive, minimally invasive and invasive techniques. Eur Respir J. 2015 Aug;46(2):521-31. doi: 10.1183/09031936.00126714. Epub 2015 May 14.
- Background: PubMed 27755785Sun J, Zhang J, Zhao H, Shen J, Gu A, Han B. Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Thorac Cancer. 2010 May;1(1):28-34. doi: 10.1111/j.1759-7714.2010.00010.x.
- Background: PubMed 24035300Sun J, Teng J, Yang H, Li Z, Zhang J, Zhao H, Garfield DH, Han B. Endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing intrathoracic tuberculosis. Ann Thorac Surg. 2013 Dec;96(6):2021-7. doi: 10.1016/j.athoracsur.2013.07.005. Epub 2013 Sep 12.
- Background: PubMed 25497069Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12.
- Background: PubMed 27882677Yang H, Wang S, Teng J, Han B, Sun J. Utility of endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing non-specific inflammatory intrathorcacic lymphadenitis. Clin Respir J. 2018 Feb;12(2):691-698. doi: 10.1111/crj.12580. Epub 2016 Nov 23.
- 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.
Jiayuan Sun, MD,PhD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 22G-ProCore Endobronchial Ultrasound Needle and 22G-Standard Endobronchial Ultrasound Needle in people with Lymph Node Disease, run by Jiayuan Sun at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, PhD (+86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of 22G-ProCore needle (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 NCT03903471, which also lists 5 linked publications.
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 Sep 2022.