Needle Aspiration Versus Forceps Biopsy for the Diagnosis of Lung Lesions With ENB

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    120
  • sponsor
    Seoul National University Bundang Hospital
Updated on 6 December 2021
bronchoscopy

Summary

This randomized crossover study aimed to compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions with electromagnetic navigation bronchoscopy, and whether combination of the two methods (needle and forceps) can provide additive benefit for diagnosis.

Description

This randomized crossover study aimed to compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions with electromagnetic navigation bronchoscopy (ENB), and whether combination of the two methods (needle and forceps) can provide additive benefit for diagnosis.

The investigators designed this study to prospectively enroll patients with lung lesions suspicious for lung cancer with positive bronchus sign and feasible for undergoing electromagnetic bronchoscopy under moderate sedation. Participants will be randomized to two groups. One group will receive ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-centered group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-centered group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy, radial endobronchial sonography. All participants will be followed up for 1 year to confirm the final diagnosis.

The primary outcome of this study will be the overall diagnostic yield of needle aspiration biopsy and forceps biopsy with ENB, and the comparison between the two methods. In addition, whether combining the two methods have resulted in a better diagnostic yield would be also evaluated.

Details
Condition Lung Disease, Lung Cancer, lung carcinoma, Lung Neoplasm, carcinoma lung, Pulmonary Disease, Bronchial Neoplasm
Treatment Device for performing biopsy via electromagnetic navigation bronchoscopy
Clinical Study IdentifierNCT05110131
SponsorSeoul National University Bundang Hospital
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with lung lesions suspicious for malignancy and needs tissue confirmation, with a positive bronchus sign and feasible for ENB

Exclusion Criteria

Patients who disagree to participate
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