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In the early stage of the study, the CT-guided micro-coil locating method for pulmonary small nodules was optimized. This study will use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.
A series of optimization and improvement measures were tried for the complications of the CT-guided micro-coil locating method. After discussion, the method of micro-coil pre-loaded in the puncture needle and sealed first, and then for subsequent locating has more advantageous. The method avoids the direct penetration of the puncture needle into the atmosphere during operation, and the operation is simpler. In vitro tests of isolated lung specimens and pre-tests of 9 clinical patients were carried out. The results showed that this method not only reduced the number of operators on site, but also had the tendency to shorten the operation time, reduce the incidence of pneumothorax, and improve the success rate. However, there is currently no rigorous scientific research to provide objective evidence for its safety and effectiveness.
Therefore, this study intends to use a single set of target values non-randomized controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil locating method in pulmonary small nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized Localization Group | Experimental | Subjects have small pulmonary nodules. In order to facilitate the search for nodules during surgery, it is necessary to indwelling markers pre-operative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized Localization Technique | Procedure | The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method. |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with pneumothorax. | Pneumothorax definition: The chest radiograph is examined in the lateral position half an hour after positioning. If a clear pneumothorax line is seen on the chest radiograph, that is, the boundary line between the atrophic lung tissue and the pleural cavity, the pneumothorax is considered to occur. | half an hour after positioning |
| Measure | Description | Time Frame |
|---|---|---|
| Positioning success rate | The proportion of patients who are successfully positioned. The CT scan was used to determine that the micro-coil was positioned around the nodules in the lungs, and the push and recovery were smooth during the operation. The components did not fall off or tear during the process, which was successful. | thoracoscopic surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li fengwei, MD | Beijing Aerospace General Hospital Thoracic surgery department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing aerospace general hospital | Beijing | Beijing Municipality | 100076 | China |
Our hospital medical ethics committee does not allow us to share patients personal data.
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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This study intends to use a single set of target values for non-randomized controlled trials, and enrolled 120 subjects who met the inclusion criteria. The small pulmonary nodules were located using an optimized pre-loaded microcoil puncture positioning method. Observe the clinical indicators such as pneumothorax incidence rate, positioning success rate, other complication rate, operation time, and number of operators, and evaluate the safety and effectiveness of the optimized CT-guided pulmonary nodule microcoil localization technique.
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| Operation time | The time interval from the first scan to the last scan to confirm that the micro coil is left in place | At the end of the positioning operation |
| Number of operators | Number of people involved in the positioning operation | At the end of the positioning operation |
| Proportion of patients with complications other than pneumothorax | thoracoscopic surgery |