Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03809169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-12
First Post:
2019-01-14
Brief Title:
Peripheral EBUS With ROSE vs no ROSE Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 28 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None