Evaluation of the synergistic impact of needle and forceps biopsy with electromagnetic navigation bronchoscopy: the CONFIDENT-ENB trial design

Yeon Wook Kim, Hyung Jun Kim, Sung Hyun Yoon, Kyung Hee Lee, Young Mi Park, So Yeon Ahn, Myung Jin Song, Byoung Soo Kwon, Sung Yoon Lim, Yeon Joo Lee, Jong Sun Park, Young Jae Cho, Ho Il Yoon, Jae Ho Lee, Choon Taek Lee

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Electromagnetic navigation bronchoscopy (ENB) is an emerging advanced imaging-guided bronchoscopy technique for diagnosing peripheral lung lesions. However, the selection strategy for the optimal biopsy device and whether adopting a multi-tool strategy increases the diagnostic yield remains undetermined. The CONFIDENT-ENB trial (NCT05110131) is a prospective randomized study on ENB, performed in a least-invasive setting. The primary aim is to evaluate whether a combination of needle aspiration and forceps biopsy improves the diagnostic performance, and assess the comparative diagnostic value and discordance of the two devices. Methods: The trial will recruit 142 participants with lung lesions suspected of malignancy who are eligible for an elective ENB procedure under moderate sedation. Participants will undergo ENB-guided needle aspiration and forceps biopsy in a randomized order without the use of any complementary techniques. All participants will be followed up subsequently for up to 12 months to conclude the final diagnosis of the biopsied lesions. Primary outcomes include the diagnostic yield and sensitivity of each biopsy modality and the diagnostic yield of the combined modalities. Discussion: The CONFIDENT-ENB trial will prospectively evaluate the synergistic effectiveness and comparative accuracy of ENB-guided needle aspiration and forceps biopsy in a least-invasive setting. The results are expected to improve our understanding of the optimal tool-selection strategy for ENB. Trial registration: ClinicalTrials.gov (NCT05110131). Prospectively registered on 5 November 2021.

Original languageEnglish
Article number319
JournalBMC Pulmonary Medicine
Volume22
Issue number1
DOIs
StatePublished - Dec 2022
Externally publishedYes

Keywords

  • Diagnostic imaging
  • Electromagnetic navigation bronchoscopy
  • Lung neoplasms
  • Pulmonary medicine

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