Stylet Use Does Not Improve Diagnostic Outcomes in Endobronchial Ultrasonographic Transbronchial Needle Aspiration: A Randomized Clinical Trial

BACKGROUND: Endobronchial ultrasonographically guided transbronchial needle aspiration (EBUS‐TBNA) of thoracic structures is a commonly performed tissue sampling technique. The use of an inner‐stylet in the EBUS needle has never been rigorously evaluated and may be unnecessary. METHODS: In a prospective randomized single‐blind controlled clinical trial, patients with a clinical indication for EBUS‐TBNA underwent lymph node sampling using both with‐stylet and without‐stylet techniques. Sample adequacy, diagnostic yield, and various cytologic quality measures were compared. RESULTS: One hundred twenty‐one patients were enrolled, with 194 lymph nodes sampled, each using both with‐stylet and without‐stylet techniques. There was no significant difference in sample adequacy or diagnostic yield between techniques. The without‐stylet technique resulted in adequate samples in 87% of the 194 study lymph nodes, which was no different from the with‐stylet adequacy rate (82%; P = .371). The with‐stylet technique resulted in a diagnosis in 50 of 194 samples (25.7%), which was similar to the without‐stylet group (49 of 194 [25.2%]; P = .740). There was a high degree of concordance in the determination of adequacy (84.0%; 95% CI, 78.1–88.9) and diagnostic sample generation (95.4%; 95% CI, 91.2–97.9) between the two techniques. A similar qualitative number of lymphocytes, malignant cells, and bronchial respiratory epithelia were recovered using each technique. CONCLUSIONS: Omitting stylet use during EBUS‐TBNA does not affect diagnostic outcomes and reduces procedural complexity. TRIAL REGISTRY: ClinicalTrials.Gov: No. NCT 02201654; URL:www.clinicaltrials.gov.