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

Seoul National University

Status: Active, not recruiting

Conditions: Lung Cancer (Diagnosis); Lung Cancer

Treatments: Device: Device for performing biopsy via electromagnetic navigation bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05110131

CONFIDENT_ENB

Details and patient eligibility

About

This randomized crossover study aimed to evaluate whether a multimodal biopsy strategy using both needle and forceps can provide additive benefits compared with a single device for diagnosing peripheral pulmonary lesions with electromagnetic navigation bronchoscopy under moderate sedation and assess the comparative yield and discordance between the two devices.

Full 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 an ENB-guided biopsy with lung lesion with needle aspiration followed by forceps biopsy (needle-first group), while the other groups will receive the same procedure with forceps biopsy followed by needle aspiration biopsy (forceps-first group). All participants will undergo ENB under moderate sedation without the concurrent use of other guiding techniques such as fluoroscopy and radial endobronchial sonography. All participants will be followed up for up to 12 months to confirm the final diagnosis.

The primary endpoint is the diagnostic accuracy of combined needle aspiration and forceps biopsy for diagnosing pulmonary lesions compared with forceps biopsy alone. Diagnostic accuracy was defined as the proportion of participants in whom the biopsy yielded 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 (true negative) without the change in diagnosis through 12 months of follow-up.

Secondary endpoints include diagnostic accuracy of the combination compared with needle aspiration alone, sensitivity for malignancy, and the strictly defined diagnostic yield determined solely based on the ENB procedural encounter, successful lesion approach, sampling duration, number of attempts for needle and forceps biopsy, and adverse events related to the ENB procedure.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with lung lesions with a possibility of malignancy and need tissue confirmation, which is eligible for ENB procedure under moderate sedation

Exclusion criteria

• Patients who disagree to participate

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

142 participants in 2 patient groups

Needle-first

Active Comparator group

Description:

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

Treatment:

Device: Device for performing biopsy via electromagnetic navigation bronchoscopy

Forceps-first

Active Comparator group

Description:

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

Treatment:

Device: Device for performing biopsy via electromagnetic navigation bronchoscopy