Spots Global Cancer Trial Database for Evaluation of the Synergistic Impact of Needle and Forceps Biopsy With Electromagnetic Navigation Bronchoscopy

Study Description

Brief 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.

Detailed Description: 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 that warrant histologic diagnosis and are 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 up to 1 year to confirm the final diagnosis. The primary endpoint is the diagnostic yield of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with individual modalities. Diagnostic yield was defined as the proportion of participants in whom the biopsy resulted in a definitive diagnosis, consistent with the strict definition; a biopsy procedure was considered diagnostic if the specimen established a definitive malignancy (true positive) or a specific benign diagnosis that sufficiently represented the lesion and informed further management Secondary endpoints include sensitivity for malignancy based on 12-month follow-up results to determine true or false negatives, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial