Lung CancerNCT03422744
EBUS-Miniprobes Sampling for Peripheral Lung Lesions
A study testing trans bronchial biopsy guided by echo-endoscopic miniprobes in people with Lung Cancer and Peripheral Pulmonary Lesions, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
There is an interest in characterazing asymptomatic peripheral lung lesions beacause they could be an early form of neoplasm. These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Peripheral Pulmonary Lesions
- What is being tested?
- trans bronchial biopsy guided by echo-endoscopic miniprobes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Aug 2017to 30 Sep 2022
- 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 presenting a peripheral lung lesion having given their approval
Who cannot join
- Lung lesion who according to ct Scan has a greater diameter lesser than 10 mm
- Ground glass lesion
- Lesion that are suspected to be a bronchopneumonia
- Contra-indication for endoscopic exam ( uncontrolled hypoxia, hypercapnia, sympotmatic bronchial hyperreactivity, recent myocardial infarction, heart failure)
- contra-indication for a transbronchial biopsy ( coagulapathy iatrogenic or not, recent uptake of anitaggregant medicines)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Peripheral Pulmonary Lesions: Benefit of Endoscopic Sample Under Fluoroscopic Controle After Non Contributive Endoscopic Samples Guided by Radial EBUS-miniprobe.
There is an interest in characterazing asymptomatic peripheral lung lesions beacause they could be an early form of neoplasm.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
Read more
The trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes can be used to collect tissue sample.
When no diagnosis is made with this technique, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).
In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.
People presenting with a peripheral lung lesion, invisible with a classical endoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.
If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.
If there isn't a diagnosis after this first exam, a second exam will be proposed to the participants including an histologic smear, a trans bronchial biopsy and a fine needle aspiration under fluoroscopic guidance.
Read the detailed description
Because of the more frequent use of thoracic imaging by ct-scan, there are a growing number of asymptomatic peripheral lung lesions that are revealed.
As they could be a be an early form of pulmonary neoplasm, it is important for the patient that a definitive diagnosis is made.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
The first guided technique was the biopsy under fluoroscopic control. During the last decade, several other technique have been developed.
Among them is the trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes. This technique has the advantage of needing no exposition to ionizing radiation and lower the risk of pneumothorax, comparing with transthoracic ponction.
In a study made by Guvenc and al. in 2015 this technique achieves a diagnostic in 62 % of the cases.
When the result is negative, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).
In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.
Patients presenting with a peripheral lung lesion, invisible with a classical bronchoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.
If the lesion is spotted, the probe will be withdrawn until the most distal visible carena and the withdrawal distance will be mesured. The biospy forceps will then be introduce at the same distance from this carena and at least five biopsy will be taken.
If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.
If there isn't a diagnosis after this first exam, a second exam will be proposed to the participant including an histologic smear, a transbronchial biopsy and a fine needle aspiration under fluoroscopic guidance.
If there is still no diagnosis after this second exam, the attitude will be discussed case by case between a follow up and an other invasive diagnosis mean (transthoracic punction under ct scan control, surgery,…).
- Conditions
- Lung Cancer, Peripheral Pulmonary Lesions
- Being tested
- trans bronchial biopsy guided by echo-endoscopic miniprobes, if first one negative: samples under fluoroscopic control
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans bronchial biopsy guided by echo-endoscopic miniprobesProcedure or surgery
We get a sample trough transbronchial biopsy guided by echo-endoscopic miniprobe.
if first one negative: samples under fluoroscopic controlProcedure or surgery
If no diagnosis with first intervention we get a second sample by cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control
| Study group | Role | What they receive |
|---|---|---|
| patient with peripheral lung lesion | Experimental | Patient presenting a peripheral lung lesion seen at Ct-scan but invisible at simple endoscopy.
Intervention : trans bronchial biopsy guided by echo-endoscopic miniprobes.
Intervention: If first intervention doesn't give a diagnosis we get cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control Receives: Procedure: trans bronchial biopsy guided by echo-endoscopic miniprobes; Procedure: if first one negative: samples under fluoroscopic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Definitive anatomopathological diagnosis
Percentage Definitive anatomopathological diagnosis obtained via the pathological exam of microscopic evaluation, immunostaining and/ or molecular analysis)
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 posted6 Feb 2018
- Study start3 Aug 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: not enough recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Marie Bruyneel, MD PhD, Principal investigator, CHU St Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422744
- Sponsor's protocol ID
- B076201733056
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Peripheral Pulmonary Lesions: Benefit of Endoscopic Sample Under Fluoroscopic Controle After Non Contributive Endoscopic Samples Guided by Radial EBUS-miniprobe.
- ClinicalTrials.gov ID
- NCT03422744
- Acronym / sponsor ID
- B076201733056
- Conditions
- Lung Cancer, Peripheral Pulmonary Lesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough recruitement
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Feb 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.
There is an interest in characterazing asymptomatic peripheral lung lesions beacause they could be an early form of neoplasm.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
The trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes can be used to collect tissue sample.
When no diagnosis is made with this technique, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).
In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.
People presenting with a peripheral lung lesion, invisible with a classical endoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.
If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.
If there isn't a diagnosis after this first exam, a second exam will be proposed to the participants including an histologic smear, a trans bronchial biopsy and a fine needle aspiration under fluoroscopic guidance.
Detailed description
Because of the more frequent use of thoracic imaging by ct-scan, there are a growing number of asymptomatic peripheral lung lesions that are revealed.
As they could be a be an early form of pulmonary neoplasm, it is important for the patient that a definitive diagnosis is made.
These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.
The first guided technique was the biopsy under fluoroscopic control. During the last decade, several other technique have been developed.
Among them is the trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes. This technique has the advantage of needing no exposition to ionizing radiation and lower the risk of pneumothorax, comparing with transthoracic ponction.
In a study made by Guvenc and al. in 2015 this technique achieves a diagnostic in 62 % of the cases.
When the result is negative, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).
In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.
Patients presenting with a peripheral lung lesion, invisible with a classical bronchoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.
If the lesion is spotted, the probe will be withdrawn until the most distal visible carena and the withdrawal distance will be mesured. The biospy forceps will then be introduce at the same distance from this carena and at least five biopsy will be taken.
If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.
If there isn't a diagnosis after this first exam, a second exam will be proposed to the participant including an histologic smear, a transbronchial biopsy and a fine needle aspiration under fluoroscopic guidance.
If there is still no diagnosis after this second exam, the attitude will be discussed case by case between a follow up and an other invasive diagnosis mean (transthoracic punction under ct scan control, surgery,…).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with peripheral lung lesion | Experimental | Procedure: trans bronchial biopsy guided by echo-endoscopic miniprobes, Procedure: if first one negative: samples under fluoroscopic controlPatient presenting a peripheral lung lesion seen at Ct-scan but invisible at simple endoscopy. Intervention : trans bronchial biopsy guided by echo-endoscopic miniprobes. Intervention: If first intervention doesn't give a diagnosis we get cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting a peripheral lung lesion having given their approval
Key exclusion criteria (5 listed)
- Lung lesion who according to ct Scan has a greater diameter lesser than 10 mm
- Ground glass lesion
- Lesion that are suspected to be a bronchopneumonia
- Contra-indication for endoscopic exam ( uncontrolled hypoxia, hypercapnia, sympotmatic bronchial hyperreactivity, recent myocardial infarction, heart failure)
- contra-indication for a transbronchial biopsy ( coagulapathy iatrogenic or not, recent uptake of anitaggregant medicines)
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 |
|---|---|---|
| trans bronchial biopsy guided by echo-endoscopic miniprobesWe get a sample trough transbronchial biopsy guided by echo-endoscopic miniprobe. | Procedure or surgery | patient with peripheral lung lesion |
| if first one negative: samples under fluoroscopic controlIf no diagnosis with first intervention we get a second sample by cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control | Procedure or surgery | patient with peripheral lung lesion |
Primary outcome
Percentage Definitive anatomopathological diagnosis
Time frame: 1 week
Percentage Definitive anatomopathological diagnosis obtained via the pathological exam of microscopic evaluation, immunostaining and/ or molecular analysis)
Results and safety
The study was stopped early (reason given: not enough recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Endobronchial ultrasound in the management of nonsmall cell lung cancerLink provided by the sponsor.
- Computed Tomography Characteristics Predictive for Radial EBUS-Miniprobe-Guided Diagnosis of Pulmonary LesionsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Marie Bruyneel, MD PhD principal investigator
CHU St Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans bronchial biopsy guided by echo-endoscopic miniprobes in people with Lung Cancer and Peripheral Pulmonary Lesions, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 5 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: stopped early, as of the sponsor's last update on 18 Jan 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 Belgium. 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 was stopped early (reason given: not enough recruitement). Results are not available in the source record.
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?
Percentage Definitive anatomopathological diagnosis (time frame: 1 week). 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 18 Jan 2023.