Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Neoplasm
- Sponsor
- Chang Chen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Accuracy of Lung Nodule Localization
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Chang Chen
Chief of thoracic surgery
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Accuracy of Lung Nodule Localization
Time Frame: 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 Outcomes
- Procedural Duration of the Nodule Localization(From the time of completing final CT scan, assessed up to 1 hour.)
- Radiation Dose(From the time of completing final CT scan, assessed up to 1 hour.)
- Complication Rate(From the time of completing final CT scan, assessed up to 2 days.)