Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Study Overview
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Brief Summary
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The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.

Detailed Description
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Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.

Official Title
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Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial

Conditions
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Lung Neoplasm, Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Device: template-guided localization
* Other: CT-guided localization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 19 to 80 years lesions located in peripheral lung tissue which can be removed by wedge resection The maximum diameter of the lesion is no more than 20 mm. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization Informed consent was signed voluntarily. Exclusion Criteria: nodule located in the scapula region. there were two or more lung nodules needed to be localized.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: CT-guided localization<br>This group of participants received conventional CT-guided lung nodule localization. | Other: CT-guided localization<br>* Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.<br>|
| Experimental: template-guided localization<br>Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization. | Device: template-guided localization<br>* Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Lung Nodule Localization | Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.) | From the time of completing final CT scan, assessed up to 2 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Duration of the Nodule Localization | Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan. | From the time of completing final CT scan, assessed up to 1 hour. | 
| Radiation Dose | Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage. | From the time of completing final CT scan, assessed up to 1 hour. | 
| Complication Rate | Pnuemothorax related to lung nodule localization | From the time of completing final CT scan, assessed up to 2 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Printing, Three-dimensional