Peripheral Pulmonary LesionsNCT01863836
Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance
A study testing Fluoroscopy and Radial EBUS-guided biopsy in people with Peripheral Pulmonary Lesions, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions
- What is being tested?
- Fluoroscopy and Radial EBUS-guided biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Apr 2015
- 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
- Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
- Adults over the age of 18
Who cannot join
- Therapeutic anticoagulation
- Antiplatelet therapy other than aspirin
- Known hemorrhagic diathesis
- Acute respiratory failure
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval
Québec, Quebec, G1V 4G5
About this study
Official title: Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions
The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).
Read the detailed description
See above
- Conditions
- Peripheral Pulmonary Lesions
- Being tested
- Fluoroscopy, Radial EBUS-guided biopsy
- Keywords
- Radial endobronchial ultrasound, Peripheral lung lesion, Fluoroscopy, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyProcedure or surgery
Radial EBUS-guided biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy | Experimental | Patients will undergo bronchoscopy and radial endobronchial ultrasound-guided biopsy of a peripheral lung lesion like patients in the other group. However, single-plane fluoroscopy will be used to help locate the lesion (with the help of a steerable curette) in case of failure to locate the lesion, and it will also be used to guide tissue sampling and ensure appropriate sampling tool function. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. Receives: Procedure: Fluoroscopy; Procedure: Radial EBUS-guided biopsy |
| No fluoroscopy | Active comparator | Patients will undergo biopsy of peripheral lung lesions using radial endobronchial ultrasound guidance only, without the use of fluoroscopy. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. Receives: Procedure: Radial EBUS-guided biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement.
Measured: Upon production of pathology results, usually within 2 weeks after the test
Sensitivity and specificity
Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution.
Measured: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test
Secondary outcomes (3)
Lesion localization
Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.
Measured: Immediate (during the test)
Procedure duration
Total duration of the bronchoscopic test.
Measured: During the test
Complications
occurrence of pneumothorax (and its management), bleeding more than 50ml, sustained desaturation below 90%, cardiac dysrhythmias, or any other adverse events occuring during or after the procedure.
Measured: Immediately during the test and up to 4 hours after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Pulmonary LesionsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Delage, Laval University
- Investigators
- Antoine Delage, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863836
- Sponsor's protocol ID
- IUCPQ-20913
- Status last verified
- Sep 2016
- First submitted
- 19 Apr 2013
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions
- ClinicalTrials.gov ID
- NCT01863836
- Acronym / sponsor ID
- IUCPQ-20913
- Conditions
- Peripheral Pulmonary Lesions
- Keywords
- Radial endobronchial ultrasound, Peripheral lung lesion, Fluoroscopy, Lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 May 2013 (estimated)
- 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 purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).
Detailed description
See above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy | Experimental | Procedure: Fluoroscopy, Procedure: Radial EBUS-guided biopsyPatients will undergo bronchoscopy and radial endobronchial ultrasound-guided biopsy of a peripheral lung lesion like patients in the other group. However, single-plane fluoroscopy will be used to help locate the lesion (with the help of a steerable curette) in case of failure to locate the lesion, and it will also be used to guide tissue sampling and ensure appropriate sampling tool function. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. |
| No fluoroscopy | Active comparator | Procedure: Radial EBUS-guided biopsyPatients will undergo biopsy of peripheral lung lesions using radial endobronchial ultrasound guidance only, without the use of fluoroscopy. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
- Adults over the age of 18
Key exclusion criteria (6 listed)
- Therapeutic anticoagulation
- Antiplatelet therapy other than aspirin
- Known hemorrhagic diathesis
- Acute respiratory failure
- Pregnancy
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 |
|---|---|---|
| Fluoroscopy | Procedure or surgery | Fluoroscopy |
| Radial EBUS-guided biopsy | Procedure or surgery | Fluoroscopy, No fluoroscopy |
Primary outcome
Diagnostic yield
Time frame: Upon production of pathology results, usually within 2 weeks after the test
Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement.
Sensitivity and specificity
Time frame: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test
Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution.
3 secondary outcomes
Lesion localization
Time frame: Immediate (during the test)
Procedure duration
Time frame: During the test
Complications
Time frame: Immediately during the test and up to 4 hours after the test
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 20 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Peripheral Pulmonary Lesions
Recruiting
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
Lung; Node
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OPTIMISE Lung SABR
Non Small Cell Lung Cancer
Not yet recruitingObservational study
Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
Peripheral Pulmonary Lesions
Not yet recruiting
Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
Lung Nodule, Solitary, Lung Nodule
Enrolling by invitation
Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions
Peripheral Pulmonary Lesions (PPLs), Pulmonary Nodules
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.
Antoine Delage, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy and Radial EBUS-guided biopsy in people with Peripheral Pulmonary Lesions, run by Laval University at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 20 Sep 2016. 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 Canada. 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?
Diagnostic yield (time frame: Upon production of pathology results, usually within 2 weeks after the test). 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?
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 20 Sep 2016.