Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy

Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy

Comparison and Synergistic Evaluation of Needle Aspiration and Forceps Biopsy for Diagnosis of Lung Lesions With Electromagnetic Navigation Bronchoscopy

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.

This randomized crossover study aimed to evaluate whether combining electromagnetic navigation bronchoscopy (ENB)-guided needle aspiration and forceps biopsy provides synergistic benefits, and compare the diagnostic performance of needle aspiration biopsy and forceps biopsy for diagnosis of pulmonary lesions. 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 endpoint is the diagnostic performance of ENB-guided needle biopsy and forceps biopsy and the yield achieved by combining the modalities based on the 12-month clinical follow-up. Secondary endpoints include a comparison of successful approach to the lesion, duration of sampling time, number of attempts, and successful acquisition of core tissue between the needle and forceps biopsy techniques.

The attending physician and patient will be blinded to the randomized group and which method of biopsy (needle or forceps) would be performed first. The pulmonologist performing the ENB procedure will be informed just before the start of the procedure which group the patient is affiliated to.

Participants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy

Participants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration.

([True positive + True negative]/All biopsied performed) Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives. For pathologic results of a benign non-specific diagnosis, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Pathologic results that are non-diagnostic at index would be determined as false negatives.

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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