3D Printing for Nodule Localization

Wen-zhao ZHONG

Status: Completed

Conditions: Pulmonary Nodule, Solitary; Lung Cancer

Treatments: Procedure: Intraoperative; Procedure: CT-guided; Procedure: Preoperative; Procedure: 3D-printing guided; Drug: Methylene blue; Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT04056923

3D printing navigation

Details and patient eligibility

About

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.

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. 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

3D-printed template-guided(3D-G)

Experimental group

Description:

Intraoperative 3D-G methylene blue dye marking in the operating room

Treatment:

Procedure: Intraoperative

Drug: Methylene blue

Procedure: 3D-printing guided

CT-guided(CT-G)

Active Comparator group

Description:

Preoperative localization is performed by CT-G indocyanine green marking in the radiology department

Treatment:

Procedure: CT-guided

Procedure: Preoperative

Drug: Indocyanine Green