Peripheral Pulmonary NodulesNCT03569306
ENB in the Diagnosis of Peripheral Pulmonary Nodules
A study testing ENB and EBUS-GS in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Nodules
- What is being tested?
- ENB and EBUS-GS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2018to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are older than 18 year-old.
- Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
- Patients who agree to undergo bronchoscopy without any contraindications.
- Patients who have good compliance and sign informed consent.
Who cannot join
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Jiayuan Sun, MD,PhD, 18017321598, jysun1976@163.com
Jiayuan Sun, MD, PhD
About this study
Official title: Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
Read the detailed description
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
- Conditions
- Peripheral Pulmonary Nodules
- Being tested
- ENB, EBUS-GS
- Keywords
- Electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENBDevice
ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
EBUS-GSDevice
EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
| Study group | Role | What they receive |
|---|---|---|
| ENB-EBUS-GS group | Experimental | ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. Receives: Device: ENB; Device: EBUS-GS |
| EBUS-GS group | Active comparator | ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. Receives: Device: EBUS-GS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
Diagnostic yield is defined as proportion of true positive and true negative.
Measured: one year
Secondary outcomes (2)
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group
The operation time includes total operation time,total GS time and total EBUS time
Measured: one week
The difference of complications between ENB-EBUS-GS group and EBUS-GS group
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start4 Jul 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD,PhD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569306
- Sponsor's protocol ID
- 2017YFC0112701-1
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3.
PubMed 24401166Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.
PubMed 23649436Seijo LM, de Torres JP, Lozano MD, Bastarrika G, Alcaide AB, Lacunza MM, Zulueta JJ. Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: results from a prospective study. Chest. 2010 Dec;138(6):1316-21. doi: 10.1378/chest.09-2708. Epub 2010 Apr 30.
PubMed 20435658Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3.
PubMed 22391437Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
PubMed 21980059Zheng X, Cao L, Zhang Y, Xie F, Yang H, Liu J, Qu S, Zhang J, Sun J. A Novel Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules: A Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1730-1739. doi: 10.1513/AnnalsATS.202109-1071OC.
PubMed 35679184
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT03569306
- Acronym / sponsor ID
- 2017YFC0112701-1
- Conditions
- Peripheral Pulmonary Nodules
- Keywords
- Electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, Xiangya Hospital of Central South University
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Jun 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.
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
Detailed description
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENB-EBUS-GS group | Experimental | Device: ENB, Device: EBUS-GSENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. |
| EBUS-GS group | Active comparator | Device: EBUS-GSENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are older than 18 year-old.
- Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
- Patients who agree to undergo bronchoscopy without any contraindications.
- Patients who have good compliance and sign informed consent.
Key exclusion criteria (3 listed)
- Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
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 |
|---|---|---|
| ENBENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules. | Device | ENB-EBUS-GS group |
| EBUS-GSEBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus). | Device | EBUS-GS group, ENB-EBUS-GS group |
Primary outcome
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
Time frame: one year
Diagnostic yield is defined as proportion of true positive and true negative.
2 secondary outcomes
The difference of operation time between ENB-EBUS-GS group and EBUS-GS group
Time frame: one week
The difference of complications between ENB-EBUS-GS group and EBUS-GS group
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 24401166Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3.
- Background: PubMed 23649436Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353.
- Background: PubMed 20435658Seijo LM, de Torres JP, Lozano MD, Bastarrika G, Alcaide AB, Lacunza MM, Zulueta JJ. Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: results from a prospective study. Chest. 2010 Dec;138(6):1316-21. doi: 10.1378/chest.09-2708. Epub 2010 Apr 30.
- Background: PubMed 22391437Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3.
- Background: PubMed 21980059Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
- Derived from this study: PubMed 35679184Zheng X, Cao L, Zhang Y, Xie F, Yang H, Liu J, Qu S, Zhang J, Sun J. A Novel Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules: A Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1730-1739. doi: 10.1513/AnnalsATS.202109-1071OC.
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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 ENB and EBUS-GS in people with Peripheral Pulmonary Nodules, run by Shanghai Chest Hospital 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 4 inclusion and 3 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 6 Jul 2018. 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, MD,PhD (86-21-22200000 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?
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group (time frame: one year). 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 NCT03569306, which also lists 6 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 6 Jul 2018.