Comparison of Patient's Procedural Tolerance of EBUS-TBNA Performed Through Nasal Versus Oral Route: The NO-EBUS Randomized Clinical Trial.
Journal
Journal of bronchology & interventional pulmonology
ISSN: 1948-8270
Titre abrégé: J Bronchology Interv Pulmonol
Pays: United States
ID NLM: 101496866
Informations de publication
Date de publication:
27 Dec 2023
27 Dec 2023
Historique:
received:
10
07
2023
accepted:
21
11
2023
medline:
27
12
2023
pubmed:
27
12
2023
entrez:
27
12
2023
Statut:
aheadofprint
Résumé
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a commonly performed procedure by the bronchoscopist for the evaluation of mediastinal lesions. However, evidence directly comparing the nasal and oral routes to guide the choice of an optimal insertion approach is scanty. In this prospective, parallel-group, open-label randomized clinical trial, adults posted for a linear EBUS-TBNA examination under conscious sedation were randomized to undergo the procedure via the nasal or oral route. The primary objective was to assess the equivalence of subject-rated tolerance of EBUS-TBNA procedure in the 2 groups. Key secondary objectives were to assess the equivalence of subject-rated overall experience, willingness for a repeat procedure, operator-rated subject's tolerance, and operator-rated ease of performing the procedure. One hundred and eighty subjects were randomized in a 1:1 ratio to the nasal (n=98) or oral (n=82) group. Outcome measures were assessed by both per-protocol (PP) and intention-to-treat (ITT) analysis. Subject-rated procedural tolerance, overall satisfaction and operator's ease of performing the procedure were found to be equivalent in the 2 groups (P<0.05 in all cases for PP and ITT analysis). The operator-rated subject's tolerance was, however, nonequivalent (P=0.0596, 0.1286 for PP and ITT, respectively). Subject's willingness to undergo a repeat procedure was similar in both groups [90% CI of difference in proportions: (-0.023, 0.121) in PP and (-0.028, 0.115) in ITT analysis]. Nasal route for EBUS-TBNA could be considered where it is feasible and preferable for the patient as well as the operator.
Sections du résumé
BACKGROUND
BACKGROUND
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a commonly performed procedure by the bronchoscopist for the evaluation of mediastinal lesions. However, evidence directly comparing the nasal and oral routes to guide the choice of an optimal insertion approach is scanty.
METHODS
METHODS
In this prospective, parallel-group, open-label randomized clinical trial, adults posted for a linear EBUS-TBNA examination under conscious sedation were randomized to undergo the procedure via the nasal or oral route. The primary objective was to assess the equivalence of subject-rated tolerance of EBUS-TBNA procedure in the 2 groups. Key secondary objectives were to assess the equivalence of subject-rated overall experience, willingness for a repeat procedure, operator-rated subject's tolerance, and operator-rated ease of performing the procedure.
RESULTS
RESULTS
One hundred and eighty subjects were randomized in a 1:1 ratio to the nasal (n=98) or oral (n=82) group. Outcome measures were assessed by both per-protocol (PP) and intention-to-treat (ITT) analysis. Subject-rated procedural tolerance, overall satisfaction and operator's ease of performing the procedure were found to be equivalent in the 2 groups (P<0.05 in all cases for PP and ITT analysis). The operator-rated subject's tolerance was, however, nonequivalent (P=0.0596, 0.1286 for PP and ITT, respectively). Subject's willingness to undergo a repeat procedure was similar in both groups [90% CI of difference in proportions: (-0.023, 0.121) in PP and (-0.028, 0.115) in ITT analysis].
CONCLUSION
CONCLUSIONS
Nasal route for EBUS-TBNA could be considered where it is feasible and preferable for the patient as well as the operator.
Identifiants
pubmed: 38148668
doi: 10.1097/LBR.0000000000000960
pii: 01436970-990000000-00111
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosure: There is no conflict of interest or other disclosures.
Références
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