Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Not Applicable

Completed

• Conditions: Lung Neoplasm; Thoracic Surgery, Video-Assisted
• Interventions: Other: CT-guided localization; Device: template-guided localization

• Registration Number: NCT02952261
• Lead Sponsor: Chang Chen

Brief Summary

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

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 Timeline

• Study Start: 2016-10-24
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-25
• Results First Submitted: 2018-02-01
• Results First Submitted QC: 2018-02-01
• Results First Posted: 2018-10-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-01
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-guided localization	CT-guided localization	This group of participants received conventional CT-guided lung nodule localization.
template-guided localization	template-guided localization	Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.

Primary Outcome Measures

Name	Time	Method
Accuracy of Lung Nodule Localization	From the time of completing final CT scan, assessed up to 2 days.	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.)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China