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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-11-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Lung Cancer (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover design

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Needle-first

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

Group Type ACTIVE_COMPARATOR

Device for performing biopsy via electromagnetic navigation bronchoscopy

Intervention Type DEVICE

Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

Forceps-first

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

Group Type ACTIVE_COMPARATOR

Device for performing biopsy via electromagnetic navigation bronchoscopy

Intervention Type DEVICE

Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

Interventions

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Device for performing biopsy via electromagnetic navigation bronchoscopy

Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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