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

Study Overview
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Brief Summary
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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
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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 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.

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

Conditions
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Lung Cancer, Lung Cancer (Diagnosis)

Intervention / Treatment
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* Device: Device for performing biopsy via electromagnetic navigation bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle-centered<br>Participants affiliated to this arm will undergo ENB-guided biopsy with needle aspiration first, followed by forceps biopsy | Device: Device for performing biopsy via electromagnetic navigation bronchoscopy<br>* Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)<br>|
| Active Comparator: Forceps-centered<br>Participants affiliated to this arm will undergo ENB-guided biopsy with forceps first, followed by needle aspiration. | Device: Device for performing biopsy via electromagnetic navigation bronchoscopy<br>* Device for performing biopsy via electromagnetic navigation bronchoscopy (needle and forceps)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield at 12 months | ([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. | Confirmed by follow-up results at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield at index | The proportion of pathologic results that leads to a specific malignant or benign diagnosis | At index procedure | 
| Sensitivity of needle or forceps biopsy for diagnosis of malignancy | True positive/Confirmed malignancy cases | Confirmed by follow-up results at 12 months | 
| Duration of procedure | Total duration and time per sampling for needle and forceps biopsy | At index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Diagnosis