Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Chang Chen

Status: Completed

Conditions: Thoracic Surgery, Video-Assisted; Lung Neoplasm

Treatments: Device: template-guided localization; Other: CT-guided localization

Study type: Interventional

Funder types: Other

Identifiers

NCT02952261

k16-284

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

CT-guided localization

Other group

Description:

This group of participants received conventional CT-guided lung nodule localization.

Treatment:

Other: CT-guided localization

template-guided localization

Experimental group

Description:

Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.

Treatment:

Device: template-guided localization