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This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a real-time non-invasive localization. The study will be conducted between July 2024 and July 2025, involving 40 patients with multiple lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or real-time non-invasive localization. The primary outcome measure will be the successful resection rate of pulmonary nodules. Secondary outcome measures will include resection margins, changes in operative approach, intraoperative blood loss, operative time, postoperative hospitalization days, the placement of chest tubes, the duration of chest tube placement, and postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive group | Experimental | Real-time non-invasive localization of multiple pulmonary nodules |
|
| CT-guided group | Active Comparator | Manual CT-guided percutaneous needle localization of multiple pulmonary nodules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual needle localization | Procedure | Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization. After confirming the needle tip's proximity to the target nodule, indocyanine green (ICG) was injected during deep inspiration to mark the nodule for intraoperative fluorescence imaging. The thoracic surgeon completed resection of the pulmonary nodule based on the area delineated by ICG. |
| Measure | Description | Time Frame |
|---|---|---|
| The successful resection rate of pulmonary nodules | The proportion of target lung nodules that are successfully localized and completely resected during the operation, with the target lesion identified in the resected specimen and negative surgical margins confirmed on final pathology. | Day of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Resection margins | Distance from the nodule to the resection margin | Day of surgery. |
| Changes in operative approach | During surgery, the planned approach must be changed when the target nodule cannot be completely resected due to various reasons. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated of Guangzhou Medical University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Real-time non-invasive localization | Procedure | The patient underwent a CT scan prior to surgery. The acquired CT image data was saved in DICOM format and subsequently imported into software for three-dimensional reconstruction of the lung lobes, blood vessels, and bronchi. During the procedure, an assistant created a three-dimensional lung model on a separate monitor, aligning it roughly with the orientation of the deflated lung observed via thoracoscopy. The thoracic surgeon then completed resection of the pulmonary nodule guided by the surgeon's three-dimensional lung model. |
|
| Day of surgery. |
| Intraoperative blood loss | Hemorrhage during surgery. | Day of surgery. |
| Operative time | Total duration of the thoracic surgical procedure, measured in minutes from skin incision to completion of skin closure for the index operation. | Day of surgery. |
| Postoperative hospitalization days | The postoperative hospitalization duration refers to the total number of days the patient remains in the hospital from the completion of surgery until discharge. | Perioperative. |
| The placement of chest tubes | Determine whether a chest tube needs to be placed based on the patient's condition during surgery. | Day of surgery. |
| The duration of chest tube placement | The chest tube placement duration refers to the number of days from the placement of the chest tube after surgery until its removal. | Perioperative. |
| Postoperative complications | Postoperative complications refer to any adverse events or symptoms that occur after surgery. | Perioperative. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |