Diagnostic Yield and Synergistic Impact of Needle Aspiration and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Controlled Trial.

Abstract

Electromagnetic navigation bronchoscopy (ENB) is an advanced imaging-guided technique used to diagnose peripheral pulmonary lesions. However, the optimal strategy for selecting biopsy devices remains unclear. Does the combination of needle aspiration and forceps biopsy improve diagnostic yield compared with using a single device alone? We conducted a randomized crossover study during ENB performed under moderate sedation. This trial recruited participants with peripheral pulmonary lesions requiring biopsy who were eligible for elective ENB. ENB-guided needle aspiration and forceps biopsy were sequentially performed in a randomized order. The primary outcome was diagnostic yield, defined as the percentage of patients for whom the biopsy provided a specific diagnosis able to inform patient management. The diagnostic yield achieved by each biopsy modality individually and in combination was evaluated. Between December 1, 2021, and November 13, 2023, 142 participants were enrolled and underwent the study procedures. Complete follow-up data were obtained for 140 participants. Diagnostic yield was 44.4% (63 of 142) for forceps biopsy, 51.4% (73 of 142) for needle aspiration (P = .221 vs forceps), and 66.9% (95 of 142) for the combination (P < .001 vs forceps alone, P < .001 vs needle alone). Sensitivities for malignancy were 47.5% (57 of 120) for forceps biopsy and 58.3% (70 of 120) for needle aspiration (P = .074). The combination of the 2 modalities resulted in a significantly improved sensitivity of 71.7% (86 of 120) compared with either individual modality (P < .001 vs forceps alone and needle alone). Pneumothorax occurred in 3.5% (5 of 142) of patients, and 1.4% (2 of 142) developed pneumothorax requiring tube drainage. Our results show that when performing ENB under moderate sedation, the combination of needle aspiration and forceps biopsy significantly improves the diagnostic yield and sensitivity for malignancy compared with each modality alone, with a favorable safety profile. These results indicate that a multimodal approach using needles and forceps is a valid diagnostic strategy for ENB. ClinicalTrials.gov; No.: NCT05110131; URL: www. gov.