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A randomized controlled trial evaluating airway inspection effectiveness during endobronchial ultrasound bronchoscopy.

ABSTRACT: BACKGROUND:Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) has revolutionized the evaluation of patients with mediastinal and hilar adenopathy. Limitations of conventional endobronchial ultrasound (C-EBUS) bronchoscopes include the inability to perform a complete airway inspection, low definition optics, and limited maneuverability. These limitations require the use of a standard bronchoscope to perform an airway examination prior to the EBUS procedure. Recently, a hybrid endobronchial ultrasound (H-EBUS) bronchoscope with high definition optics and increased maneuverability has been introduced. Our objective was to assess the ability of H-EBUS to perform a full airway inspection and TBNA. METHODS:Patients referred for EBUS-TBNA were prospectively randomized to either form of EBUS from November 2013 to January 2014. The primary outcome was the airway segment visualization in each lobe using an EBUS bronchoscope. Secondary outcomes included the number of bronchoscopes used per procedure, procedure length, diagnostic yield and specimen adequacy. RESULTS:Sixty-two consecutive patients undergoing EBUS-TBNA were randomized to H-EBUS (n=30) or C-EBUS (n=32). In cases in which EBUS-TBNA was the only procedure performed (n=32), use of a second bronchoscope to perform an adequate airway inspection was significantly higher in C-EBUS compared to H-EBUS (5 vs. 0, P=0.046). There was better segmental visualization achieved in multiple lobes when using H-EBUS (P<0.01). No differences in TBNA sample diagnostic yield, specimen adequacy or procedure time were noted when comparing bronchoscopes (P= NS). CONCLUSIONS:Use of an H-EBUS may improve the ability to perform an adequate airway inspection potentially obviating the need for a conventional bronchoscope.

SUBMITTER: Yarmus L

PROVIDER: S-EPMC4635275 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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A randomized controlled trial evaluating airway inspection effectiveness during endobronchial ultrasound bronchoscopy.

Yarmus Lonny L Akulian Jason J Ortiz Ricardo R Thompson Richard R Oakjones-Burgess Karen K Arias Sixto S Semaan Roy R Feller-Kopman David D Lee Hans H Wang Ko Pen KP

Journal of thoracic disease 20151001 10

<h4>Background</h4>Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) has revolutionized the evaluation of patients with mediastinal and hilar adenopathy. Limitations of conventional endobronchial ultrasound (C-EBUS) bronchoscopes include the inability to perform a complete airway inspection, low definition optics, and limited maneuverability. These limitations require the use of a standard bronchoscope to perform an airway examination prior to the EBUS procedure. Recently, a ...[more]

PMID: 26623106

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Project description:Autologous hematopoietic stem cell transplantation (ASCT) improves survival in multiple myeloma (MM). However, up to 30% of MM patients are unable to collect optimal numbers of peripheral blood (PB) CD34+ hematopoietic stem and progenitor cells (HSPCs) with standard G-CSF mobilization. Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended receptor occupancy and enhanced in-vivo activity. The GENESIS Trial is a prospective, phase III, double-blind, placebo-controlled, international, multicenter, superiority trial with 122 adult patients randomized (2:1) to motixafortide+G-CSF or placebo+G-CSF for HSPC mobilization for ASCT in MM (NCT03246529). The primary endpoint of the study was met, with motixafortide+G-CSF enabling 92.5% of patients to collect ≥6x106 CD34+ cells/kg within 2 apheresis procedures versus 26.2% with placebo+G-CSF (p<0.0001). A key, prespecified secondary endpoint was also met, with motixafortide+G-CSF enabling 88.8% of patients to collect ≥6x106 CD34+ cells/kg in 1 apheresis versus 9.5% with placebo+G-CSF (p<0.0001). Motixafortide+G-CSF was safe and well-tolerated, with the most common treatment-emergent adverse events observed being transient, Grade 1/2 injection site reactions (pain: 50%, erythema: 27.5%, pruritis: 21.3%). In addition, extended immunophenotyping and single-cell transcriptional profiling were performed on CD34+ HSPCs mobilized on the GENESIS Trial, as well as a contemporaneous MM cohort undergoing plerixafor+G-CSF mobilization for ASCT and 3 cohorts of allogeneic HSPC donors undergoing single-agent mobilization with motixafortide, plerixafor or G-CSF alone. Motixafortide+G-CSF resulted in a 10.5-fold increase in primitive HSPCs collected versus placebo+G-CSF (p<0.0001); and significantly greater numbers of early stem and progenitors versus both placebo+G-CSF (p<0.0001) and plerixafor+G-CSF (p=0.0327). Motixafortide also preferentially mobilized HSPC subsets with upregulated gene expression pathways associated with enhanced self-renewal, regeneration and quiescence (EGF, NFB/TNF and HBO1). In conclusion, motixafortide+G-CSF mobilized significantly greater CD34+ HSPC numbers within 2 apheresis procedures versus placebo+G-CSF. Motixafortide also preferentially mobilized primitive stem and early progenitor cells with unique transcriptional profiles versus plerixafor and G-CSF.

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A randomized controlled trial evaluating airway inspection effectiveness during endobronchial ultrasound bronchoscopy.

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A randomized controlled trial evaluating airway inspection effectiveness during endobronchial ultrasound bronchoscopy.

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