Clinical trial NCT04552054: Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules
Official title: Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Video-assisted Thoracic Surgery
Lung Cancer
Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Keywords: pulmonary nodule
localization
three-dimensional printing
mixed reality
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2020-09-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Puncture success rate of localization
timeFrame: During surgery
Secondary outcomes:
measure: Time of localization
timeFrame: During surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wen-Zhao Zhong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: