Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules (MR&3D Local)

Wen-zhao ZHONG

Status: Unknown

Conditions: Pulmonary Nodule, Multiple; Video-assisted Thoracic Surgery; Pulmonary Nodule, Solitary; Lung Cancer

Treatments: Device: Computerized Tomography guided localization; Device: Mixed Reality+ 3D printing guided localization

Study type: Interventional

Funder types: Other

Identifiers

NCT04552054

46783912

Details and patient eligibility

About

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

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

CT guided localization

Active Comparator group

Description:

Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization

Treatment:

Device: Computerized Tomography guided localization

MR+3D guided localization

Experimental group

Description:

Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization

Treatment:

Device: Mixed Reality+ 3D printing guided localization