Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule

Study Overview
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Brief Summary
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Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

Detailed Description
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Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Official Title
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Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: AF-guided endobronchial marking
* Device: ENB-guided endobronchial marking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20 90 years old C. sign permit Exclusion Criteria: A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-op<br> | Procedure: AF-guided endobronchial marking<br>* Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance<br>|
| Active Comparator: Intra-op<br> | Device: ENB-guided endobronchial marking<br>* Bronchoscopic dye marking with ENB system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful localization | Discrepancy from lesion to marking: less than 1 cm | 2 days | 
| Successful resection | Lesion contained in first resected specimen | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization duration | Total time span of localization procedure | 1 day | 
| Total radiation exposure | Radiation during entire localization procedure | 2 days | 
| Complication | Procedure related complication | 14 days |