Application of 3D Printing Technique in Small Pulmonary Nodule Localization

Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952261
• Other study ID #: k16-284
• Status: Completed
• Phase: N/A
• Start date: October 24, 2016
• Est. completion date: October 25, 2017

Study information

• Verified date: December 2018
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 25, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Thoracic Surgery, Video-Assisted

Intervention

Device:
• template-guided localization
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.

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

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chang Chen

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhang L, Li M, Li Z, Kedeer X, Wang L, Fan Z, Chen C. Three-dimensional printing of navigational template in localization of pulmonary nodule: A pilot study. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2113-2119.e7. doi: 10.1016/j.jtcvs.2017.08.065. Epub 2017 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Complication Rate	Pnuemothorax related to lung nodule localization	From the time of completing final CT scan, assessed up to 2 days.