3D Printing for Nodule Localization

Study Overview
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Brief Summary
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Implementation of lung cancer screening using low-dose computed tomography has increased the rate of detection of small peripheral pulmonary nodules. However, it is hard to localize these nodules by palpation because of their small volume and long distance to the nearest pleural surface. To further clarify the confounding factors, we developed our own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, our procedure was performed in the operating room without CT scan evaluation.

Detailed Description
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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. In recent years, the three-dimensional (3D) printing technique has been gradually applied to clinical therapy. However, 3D-printed template-guided (3D-G) localization required pre-evaluation by CT scanning. If deviation of more than 2 cm was found on the CT scan, the 3D-G method was regarded as a failure and traditional CT-G hookwire localization was used. To further clarify the confounding factors, the investigators developed their own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, the 3D printing localization procedure was performed in the operating room without CT scan evaluation.

Official Title
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Three-dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules

Conditions
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Pulmonary Nodule, Solitary, Lung Cancer

Intervention / Treatment
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* Procedure: 3D-printing guided
* Procedure: CT-guided
* Drug: Indocyanine Green
* Drug: Methylene blue
* Procedure: Preoperative
* Procedure: Intraoperative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a maximum target lung nodule diameter ≤20 mm; a target nodule consolidation/tumor ratio (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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed template-guided(3D-G)<br>Intraoperative 3D-G methylene blue dye marking in the operating room | Procedure: 3D-printing guided<br>* 3D printed navigational template guided<br>Drug: Methylene blue<br>* The results are shown by comparison of different colors.<br>Procedure: Intraoperative<br>* Intraoperative localization.<br>|
| Active Comparator: CT-guided(CT-G)<br>Preoperative localization is performed by CT-G indocyanine green marking in the radiology department | Procedure: CT-guided<br>* CT-guided<br>Drug: Indocyanine Green<br>* The results are shown by comparison of different colors.<br>Procedure: Preoperative<br>* Preoperative localization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization distance | The distance of the two stain points from the tumor. The investigators use a sterile, standard ruler to measure the distance. Based on our previous experience with CT-G localization, a deviation of less than 2 cm was considered a successful localization. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Nodules, Lung Neoplasms, Computed Tomography, Three-Dimensional Printing