Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT)

Expert Rev Med Devices. 2024 Nov;21(11):1049-1055. doi: 10.1080/17434440.2024.2410913. Epub 2024 Oct 7.

Abstract

Background: Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available.

Methods: Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups.

Results: A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15).

Conclusion: We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle.

Clinical trial registration: Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

Keywords: EBUS-TBNA; FNAC; endobronchial ultrasound; endoscopic ultrasound; fine needle aspiration cytology; lung cancer; randomized controlled trial.

Publication types

  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Bronchoscopy / instrumentation
  • Bronchoscopy / methods
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration* / instrumentation
  • Endoscopic Ultrasound-Guided Fine Needle Aspiration* / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Needles*