AI Article Synopsis
- The CONFIDENT-ENB trial explores the effectiveness of electromagnetic navigation bronchoscopy (ENB) in diagnosing peripheral lung lesions by evaluating if combining needle aspiration and forceps biopsy improves diagnostic performance.
- A total of 142 participants with suspected malignant lung lesions will be randomized to receive both biopsy techniques, and their outcomes will be monitored for up to 12 months.
- The study aims to clarify the best tool-selection strategy for ENB and provide insights into the performance and accuracy of both biopsy methods in a minimally invasive context.
Article 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.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9392264 | PMC |
| http://dx.doi.org/10.1186/s12890-022-02104-w | DOI Listing |
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