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.
Condition or disease | Intervention/treatment | Phase |
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Peripheral Pulmonary Lesions Lung Cancer | Procedure: Rapid on-site evaluation (ROSE) Procedure: Slim bronchoscope without a guide sheath Procedure: Standard pEBUS with guide sheath | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 208 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Start Date : | November 1, 2019 |
Estimated Primary Completion Date : | July 30, 2022 |
Estimated Study Completion Date : | October 30, 2022 |
Arm | Intervention/treatment |
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Experimental: ROSE with guide sheath
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE
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Procedure: Rapid on-site evaluation (ROSE)
Pathologist on site for direct evaluation of specimen adequacy
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Experimental: ROSE without guide sheath
Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.
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Procedure: Rapid on-site evaluation (ROSE)
Pathologist on site for direct evaluation of specimen adequacy
Procedure: Slim bronchoscope without a guide sheath 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.
Other Name: Ultrathin bronchoscope with pEBUS
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Experimental: Guide sheath without ROSE
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.
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Procedure: Standard pEBUS with guide sheath
Using a flexible bronchoscope with minimal outer diameter of 4.2mm.
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Experimental: No guide sheath without ROSE
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.
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Procedure: Slim bronchoscope without a guide sheath
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.
Other Name: Ultrathin bronchoscope with pEBUS
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Tremblay, MD | 403-210-3866 | atrembla@ucalgary.ca | |
Contact: Laila Samy, MD | 403-210-3866 | laila.samy@ucalgary.ca |
Canada, Alberta | |
Health Sciences Centre | Recruiting |
Calgary, Alberta, Canada, T2N 4N1 | |
Contact: Alain Tremblay, MDCM 403-210-3866 alain.tremblay@ucalgary.ca | |
Principal Investigator: Alain Tremblay, MDCM | |
Sub-Investigator: Laila Samy, MD | |
Sub-Investigator: Elaine Dumoulin, MD | |
Sub-Investigator: Paul MacEachern, MD | |
Sub-Investigator: Christopher Hergott, MD | |
Sub-Investigator: Anne Valerie Gonzalez, MD | |
Sub-Investigator: Marc Fortin, MD | |
Sub-Investigator: Erik Vakil, MD |
Tracking Information | |||||||||||
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First Submitted Date ICMJE | January 14, 2019 | ||||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||||
Last Update Posted Date | May 14, 2021 | ||||||||||
Actual Study Start Date ICMJE | November 1, 2019 | ||||||||||
Estimated Primary Completion Date | July 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Peripheral pulmonary lesion diagnostic yield [ Time Frame: 1 month ] | ||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath | ||||||||||
Official Title ICMJE | 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 | ||||||||||
Brief 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. 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. |
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Detailed Description | Not Provided | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||
Estimated Enrollment ICMJE |
208 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | October 30, 2022 | ||||||||||
Estimated Primary Completion Date | July 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT03809169 | ||||||||||
Other Study ID Numbers ICMJE | 88888 | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Calgary | ||||||||||
Study Sponsor ICMJE | University of Calgary | ||||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||||
PRS Account | University of Calgary | ||||||||||
Verification Date | May 2021 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |