Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules

Not Applicable

• Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary; Lung Cancer; Video-assisted Thoracic Surgery
• Interventions: Device: Computerized Tomography guided localization; Device: Mixed Reality+ 3D printing guided localization

• Registration Number: NCT04552054
• Lead Sponsor: Wen-zhao ZHONG

Brief Summary

This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.

Detailed Description

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. Mixed reality (MR) technique aims to enhance the simple self-visual effect and facilitate visualization of the surrounding environment in any situation. The three-dimensional model can be visualized by MR technique through MR glasses. Investigators project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest, and then use this as a guide for percutaneous lung puncture localization. At the same time, investigators design an three-dimensional printing navigational template based on the 3D reconstruction model and place it on the surface of the body to help to guide the localization. This study is designed to evaluates the viability and accuracy of preoperative mixed reality technique combined with 3D printing navigational template guided localizing pulmonary nodules.

Study Timeline

• Study Start: 2018-05-01
• Status Verified: 2020-05
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• a maximum target lung nodule (one or more) diameter ≤20 mm
• a target nodule CTR <0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface >10 mm if the target nodule CTR was >0·25.
• Plan to perform VATS lung wedge resection

Exclusion Criteria

• Inability to comply with research protocols or research procedures
• Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease
• Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture
• Pregnant or lactating women
• Other circumstances that the investigator believes are not suitable for enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT guided localization	Computerized Tomography guided localization	Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization
MR+3D guided localization	Mixed Reality+ 3D printing guided localization	Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization

Primary Outcome Measures

Name	Time	Method
Puncture success rate of localization	During surgery	The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.

Secondary Outcome Measures

Name	Time	Method
Time of localization	During surgery	To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China