Peripheral Pulmonary LesionsNCT03809169
Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath
A study testing Rapid on-site evaluation (ROSE), Slim bronchoscope without a guide sheath and Standard pEBUS with guide sheath in people with Peripheral Pulmonary Lesions and Lung Cancer, run by University of Calgary at 2 sites in Canada.
Trial summary
Peripheral pulmonary lesions (PPL) are defined as nodules or masses that are located in the lung periphery; hence cannot be seen via regular bronchoscopy. Due to their location, establishing a pathological diagnosis can be challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesions, Lung Cancer
- What is being tested?
- Rapid on-site evaluation (ROSE), Slim bronchoscope without a guide sheath and Standard pEBUS with guide sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2019to 30 Sep 2024
- 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
- Adults ≥ 18 years old
- Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
- The PPL appears radiologically accessible via pEBUS as assessed by an experienced interventional respirologist.
- Absence of suspicious mediastinal lymphadenopathy on non-invasive staging defined as N1, N2 or N3 nodes ≥1cm on CT or ≥ moderate uptake on PET/CT unless shown to be negative on invasive sampling. Linear EBUS sampling of nodal stations will otherwise be permitted as part of a staging procedure.
- Clinical decision made by patient and treating physician to proceed to bronchoscopy.
Who cannot join
- Other intervention indicated as primary diagnostic procedure (eg: TTNA, surgical lung biopsy, linear EBUS alone, biopsy of extra-thoracic lesion)
- Location of lesion not amenable to transbronchial needle aspiration sampling as assessed by an experienced interventional respirologist.
- Contra-indication to pEBUS or bronchoscopy such as: severe pulmonary hypertension (mean pulmonary arterial pressure of ≥25mmHg with evidence of right heart failure), unstable medical condition or uncorrected coagulopathy.
- Pregnancy
- Use of electromagnetic or other navigation system (virtual bronchoscopic planning is allowed)
- Absence of informed consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Health Sciences Centre
Calgary, Alberta, T2N 4N1
Universite Laval
Québec
About this study
Official title: Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial
Peripheral pulmonary lesions (PPL) are defined as nodules or masses that are located in the lung periphery; hence cannot be seen via regular bronchoscopy. Due to their location, establishing a pathological diagnosis can be challenging. Investigations of PPL has significantly evolved in the last decade with the development of new technologies such as peripheral endobronchial ultrasound (pEBUS), virtual bronchoscopy and electromagnetic navigational bronchoscopy (ENB). Although these technologies have allowed physicians to safely biopsy previously difficult to access nodules, their sensitivity have been lower than trans-thoracic needle aspiration (TTNA). In fact, the largest registry to date has found a diagnostic yield of pEBUS of 57% compared to 93% for TTNA. However, TTNA caries substantially more procedural risk than pEBUS with a 25% rate of complication vs 2.8% for pEBUS (1, 2). With increased sensitivity, pEBUS could become the procedure of choice for PPL investigation in view of its safety profile. Rapid on-site evaluation of biopsy samples by a cytopathologist (ROSE) allows for direct evaluation of specimen adequacy. By offering real-time feedback to the bronchoscopist about specimen adequacy, the adding of ROSE to pEBUS could lead to an increase in diagnostic yield, allowing for a faster diagnosis of lung cancer and avoiding the need for further diagnostic procedures. Minitiazuration of broncoscopes can also allow navigation to more distal areas of the lung closer to the PPL. While this may also improve diagnostic yield, other technical modification such as the need for smaller sampling instruments and inability to use a guide sheath may have drawbacks.
This study will use a 2 x 2 factorial design to compare diagnostic yield of pEBUS bronchoscopic PPL sampling with vs. without ROSE as well as with a novel "slim" bronchoscope vs. standard bronchoscope. The investigators aim to randomize 208 patients to independently test each hypothesis.
- Conditions
- Peripheral Pulmonary Lesions, Lung Cancer
- Being tested
- Rapid on-site evaluation (ROSE), Slim bronchoscope without a guide sheath, Standard pEBUS with guide sheath
- Keywords
- peripheral endobronchial ultrasound, radial endobronchial ultrasound, guide sheath, ultrathin bronchoscope, peripheral pulmonary lesion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid on-site evaluation (ROSE)Procedure or surgery
Pathologist on site for direct evaluation of specimen adequacy
Slim bronchoscope without a guide sheathProcedure or surgery
Also called Ultrathin bronchoscope with pEBUS
peripheral endobronchial ultrasound performed with a slim bronchoscope (3.0 mm outer diameter with a 1.7mm channel) combined with a radial ultrasound probe but without the use of a guide sheath.
Standard pEBUS with guide sheathProcedure or surgery
Using a flexible bronchoscope with minimal outer diameter of 4.2mm.
| Study group | Role | What they receive |
|---|---|---|
| ROSE with guide sheath | Experimental | Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE Receives: Procedure: Rapid on-site evaluation (ROSE) |
| ROSE without guide sheath | Experimental | Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE. Receives: Procedure: Rapid on-site evaluation (ROSE); Procedure: Slim bronchoscope without a guide sheath |
| Guide sheath without ROSE | Experimental | Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE. Receives: Procedure: Standard pEBUS with guide sheath |
| No guide sheath without ROSE | Experimental | Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE. Receives: Procedure: Slim bronchoscope without a guide sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral pulmonary lesion diagnostic yield
Measured: 1 month
Secondary outcomes (5)
Sensitivity and specificity for malignancy
Measured: weeks up to 1 month
Total procedure time
Measured: Intraoperative
Sample adequacy for adjunctive testing if lung cancer
Sample adequacy for EGFR mutation analysis, ALK and PDL1 immunohistochemistry.
Measured: 1 month
Extra diagnostic procedure required for final diagnosis.
Measured: 6 months up to 1 year
Complications
Combination of endpoints following chart review, including but not limited to unplanned hospitalization or emergency room visit, hemoptysis, pneumothorax, chest infection, fever or exacerbation of lung disease.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Nov 2019
- Primary completion30 Mar 2024
- Study completion30 Sep 2024
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 Peripheral Pulmonary LesionsStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Laval University
- Responsible party
- Sponsor
- Investigators
- Alain Tremblay, MDCM, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809169
- Sponsor's protocol ID
- 88888
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data that underlie the results reported in this article (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal. Other accessible documents will include the study protocol. Beginning 9 months and ending 36 months following article publications, proposals may be submitted to alain.tremblay@ucalgary.ca. To gain access, data requestors will need to sign a data access agreement.
Publications
Vakil E, Fortin M, Gonzalez AV, Samy L, Chee AC, Dumoulin E, Dvorakova M, Hergott CA, Khalil M, Lampron N, MacEachern P, Martel S, Shieh B, Simon M, Soumagne T, Terzic T, Tremblay A. Ultrathin Bronchoscopy With Radial Endobronchial Ultrasound and Rapid On-Site Evaluation for the Diagnosis of Peripheral Pulmonary Lesions: A Multicenter Randomized Controlled Factorial Trial. Chest. 2025 Oct;168(4):1034-1048. doi: 10.1016/j.chest.2025.05.020. Epub 2025 May 24.
PubMed 40419109
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial
- ClinicalTrials.gov ID
- NCT03809169
- Acronym / sponsor ID
- 88888
- Conditions
- Peripheral Pulmonary Lesions, Lung Cancer
- Keywords
- peripheral endobronchial ultrasound, radial endobronchial ultrasound, guide sheath, ultrathin bronchoscope, peripheral pulmonary lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- McGill University, Laval University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Jan 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.
Peripheral pulmonary lesions (PPL) are defined as nodules or masses that are located in the lung periphery; hence cannot be seen via regular bronchoscopy. Due to their location, establishing a pathological diagnosis can be challenging. Investigations of PPL has significantly evolved in the last decade with the development of new technologies such as peripheral endobronchial ultrasound (pEBUS), virtual bronchoscopy and electromagnetic navigational bronchoscopy (ENB). Although these technologies have allowed physicians to safely biopsy previously difficult to access nodules, their sensitivity have been lower than trans-thoracic needle aspiration (TTNA). In fact, the largest registry to date has found a diagnostic yield of pEBUS of 57% compared to 93% for TTNA. However, TTNA caries substantially more procedural risk than pEBUS with a 25% rate of complication vs 2.8% for pEBUS (1, 2). With increased sensitivity, pEBUS could become the procedure of choice for PPL investigation in view of its safety profile. Rapid on-site evaluation of biopsy samples by a cytopathologist (ROSE) allows for direct evaluation of specimen adequacy. By offering real-time feedback to the bronchoscopist about specimen adequacy, the adding of ROSE to pEBUS could lead to an increase in diagnostic yield, allowing for a faster diagnosis of lung cancer and avoiding the need for further diagnostic procedures. Minitiazuration of broncoscopes can also allow navigation to more distal areas of the lung closer to the PPL. While this may also improve diagnostic yield, other technical modification such as the need for smaller sampling instruments and inability to use a guide sheath may have drawbacks.
This study will use a 2 x 2 factorial design to compare diagnostic yield of pEBUS bronchoscopic PPL sampling with vs. without ROSE as well as with a novel "slim" bronchoscope vs. standard bronchoscope. The investigators aim to randomize 208 patients to independently test each hypothesis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ROSE with guide sheath | Experimental | Procedure: Rapid on-site evaluation (ROSE)Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE |
| ROSE without guide sheath | Experimental | Procedure: Rapid on-site evaluation (ROSE), Procedure: Slim bronchoscope without a guide sheathPatients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE. |
| Guide sheath without ROSE | Experimental | Procedure: Standard pEBUS with guide sheathPatients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE. |
| No guide sheath without ROSE | Experimental | Procedure: Slim bronchoscope without a guide sheathPatients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years old
- Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
- The PPL appears radiologically accessible via pEBUS as assessed by an experienced interventional respirologist.
- Absence of suspicious mediastinal lymphadenopathy on non-invasive staging defined as N1, N2 or N3 nodes ≥1cm on CT or ≥ moderate uptake on PET/CT unless shown to be negative on invasive sampling. Linear EBUS sampling of nodal stations will otherwise be permitted as part of a staging procedure.
- Clinical decision made by patient and treating physician to proceed to bronchoscopy.
Key exclusion criteria (6 listed)
- Other intervention indicated as primary diagnostic procedure (eg: TTNA, surgical lung biopsy, linear EBUS alone, biopsy of extra-thoracic lesion)
- Location of lesion not amenable to transbronchial needle aspiration sampling as assessed by an experienced interventional respirologist.
- Contra-indication to pEBUS or bronchoscopy such as: severe pulmonary hypertension (mean pulmonary arterial pressure of ≥25mmHg with evidence of right heart failure), unstable medical condition or uncorrected coagulopathy.
- Pregnancy
- Use of electromagnetic or other navigation system (virtual bronchoscopic planning is allowed)
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 |
|---|---|---|
| Rapid on-site evaluation (ROSE)Pathologist on site for direct evaluation of specimen adequacy | Procedure or surgery | ROSE with guide sheath, ROSE without guide sheath |
| Slim bronchoscope without a guide sheathAlso: Ultrathin bronchoscope with pEBUSperipheral endobronchial ultrasound performed with a slim bronchoscope (3.0 mm outer diameter with a 1.7mm channel) combined with a radial ultrasound probe but without the use of a guide sheath. | Procedure or surgery | No guide sheath without ROSE, ROSE without guide sheath |
| Standard pEBUS with guide sheathUsing a flexible bronchoscope with minimal outer diameter of 4.2mm. | Procedure or surgery | Guide sheath without ROSE |
Primary outcome
Peripheral pulmonary lesion diagnostic yield
Time frame: 1 month
5 secondary outcomes
Sensitivity and specificity for malignancy
Time frame: weeks up to 1 month
Total procedure time
Time frame: Intraoperative
Sample adequacy for adjunctive testing if lung cancer
Time frame: 1 month
Extra diagnostic procedure required for final diagnosis.
Time frame: 6 months up to 1 year
Complications
Time frame: 48 hours
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 5 Dec 2024.
- Derived from this study: PubMed 40419109Vakil E, Fortin M, Gonzalez AV, Samy L, Chee AC, Dumoulin E, Dvorakova M, Hergott CA, Khalil M, Lampron N, MacEachern P, Martel S, Shieh B, Simon M, Soumagne T, Terzic T, Tremblay A. Ultrathin Bronchoscopy With Radial Endobronchial Ultrasound and Rapid On-Site Evaluation for the Diagnosis of Peripheral Pulmonary Lesions: A Multicenter Randomized Controlled Factorial Trial. Chest. 2025 Oct;168(4):1034-1048. doi: 10.1016/j.chest.2025.05.020. Epub 2025 May 24.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data that underlie the results reported in this article (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal. Other accessible documents will include the study protocol. Beginning 9 months and ending 36 months following article publications, proposals may be submitted to alain.tremblay@ucalgary.ca. To gain access, data requestors will need to sign a data access agreement.
Related trials for Peripheral Pulmonary Lesions
Recruiting
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
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OPTIMISE Lung SABR
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Not yet recruitingObservational study
Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
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Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
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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.
Alain Tremblay, MDCM principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid on-site evaluation (ROSE), Slim bronchoscope without a guide sheath and Standard pEBUS with guide sheath in people with Peripheral Pulmonary Lesions and Lung Cancer, run by University of Calgary at 2 sites 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 5 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Peripheral pulmonary lesion diagnostic yield (time frame: 1 month). 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 NCT03809169, 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 5 Dec 2024.