Diagnostic Yield and Synergistic Impact of Needle Aspiration and Forceps Biopsy with Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions (CONFIDENT-ENB): A Randomized Controlled Trial.

Abstract

Background: 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.

Research question: Does the combination of needle aspiration and forceps biopsy improve diagnostic yield compared with that using a single device alone?

Study design and methods: 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.

Results: 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% (63/142) for forceps biopsy, 51.4% (73/142) for needle aspiration (p=0.221 vs. forceps), and 66.9% (95/142) for the combination (p<0.001 vs. forceps alone, p<0.001 vs. needle alone). Sensitivities for malignancy were 58.3% (70/120) for needle aspiration and 47.5% (57/120) for forceps biopsy (p=0.074). The combination of the two modalities resulted in a significantly improved sensitivity of 71.7% (86/120) compared with either individual modality (p<0.001 vs. forceps alone and needle alone). Pneumothorax occurred in 3.5% (5/142) of patients, and 1.4% (2/142) developed pneumothorax requiring tube drainage.

Interpretation: When performing ENB under moderate sedation, the combination of needle aspiration and forceps biopsy significantly improves the diagnostic yield and sensitivity for malignancy compared to 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.

Clinical trial registration: NCT05110131.