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| Name | Class |
|---|---|
| Zhuhai Seine Technology Co., Ltd, Zhuhai city, China | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-printed template-guided(3D-G) | Experimental | Intraoperative 3D-G methylene blue dye marking in the operating room |
|
| CT-guided(CT-G) | Active Comparator | Preoperative localization is performed by CT-G indocyanine green marking in the radiology department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-printing guided | Procedure | 3D printed navigational template guided |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D008175 | Lung Neoplasms |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| CT-guided |
| Procedure |
CT-guided |
|
| Indocyanine Green | Drug | The results are shown by comparison of different colors. |
|
| Methylene blue | Drug | The results are shown by comparison of different colors. |
|
| Preoperative | Procedure | Preoperative localization. |
|
| Intraoperative | Procedure | Intraoperative localization. |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |