Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Chang Chen200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Lung Neoplasm Thoracic Surgery, Video-Assisted

Interventions

template-guided localizationDEVICE

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.

CT-guided localizationOTHER

Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged from 19 to 80 years 2. lesions located in peripheral lung tissue which can be removed by wedge resection 3. The maximum diameter of the lesion is no more than 20 mm. 4. Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization 5. Informed consent was signed voluntarily. Exclusion Criteria: 1. nodule located in the scapula region. 2. there were two or more lung nodules needed to be localized.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.)

Time frame: From the time of completing final CT scan, assessed up to 2 days.

Secondary Outcomes

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.

Time frame: 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.

Time frame: From the time of completing final CT scan, assessed up to 1 hour.

Complication Rate

Pnuemothorax related to lung nodule localization

Time frame: From the time of completing final CT scan, assessed up to 2 days.

Data from ClinicalTrials.gov

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