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The aim of this study is to investigate the efficacy and safety of Cryoablation and Thoracoscopic Surgery in the treatment of pulmonary ground-glass nodules.
The primary treatment for GGN type lung cancer is surgical resection, typically using video-assisted thoracoscopic surgery (VATS). Image-guided ablation therapy is considered as a treatment option for early-stage lung cancer patients unsuitable for surgery. It has been recommended by several guidelines as one of the curative treatment methods for primary lung cancer. Among various ablation techniques, cryoablation has the lowest complication rate. However, there is currently no research exploring whether cryoablation is not inferior to thoracoscopic surgery in terms of safety and efficacy in treating highly suspected malignant lung GGNs. This study is designed as a prospective, non-randomized study, with 160 patients expected to be enrolled, who will be assigned to cryoablation or video-assisted thoracoscopic surgery treatment groups based on patient preference. The primary endpoint is the 2-year disease-free survival. Secondary endpoints include 1-month mortality rate, overall survival, 5-year disease-free survival, local recurrence rate, VATS/ cryoablation completion rate, safety, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation group | Experimental | Ground-glass nodules were treated using cryoprobe by transbronchial or percutaneous method. |
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| Thoracoscopic Surgery group | Active Comparator | Ground-glass nodules were treated by video-assisted thoracoscopic surgery (VATS). Based on the location of the GGN, select the appropriate surgical resection range (wedge resection, segmentectomy, lobectomy, or combined segmentectomy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease-free survival | Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 1-month mortality rate | The proportion of patients who die within one month after treatment. | 1 month after the treatment |
| Overall survival | Defined as the time from enrollment to death from any cause, or to the last contact with surviving patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | +86-021-22200000 | 1511 | xkyyjysun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D013906 | Thoracoscopy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
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| Thoracoscopic Surgery | Procedure | The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery. |
|
| Up to 2 years, 5years |
| 5-year disease-free survival | Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause. | Up to 5 years |
| Local recurrence rate | The proportion of patients who experience disease recurrence at the original treatment site. | Up to 5 years |
| VATS/ cryoablation completion rate | The proportion of patients in whom VATS or cryoablation is successfully completed. | immediately after the treatment |
| Forced Expiratory Volume in 1 Second (FEV1) | The maximum volume of air exhaled in the first second during a forced expiration following maximal inhalation. | 3 months after the treatment |
| Forced Vital Capacity (FVC) | The total volume of air exhaled as forcefully and completely as possible after maximal inhalation. | 3 months after the treatment |
| Adverse events and serious adverse events | Complications at 3 months after the treatment will be assessed using the Clavien-Dindo classification of surgical complications. Aderse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 3 months after the treatment |
| Quality of life assessment | Pain scores. | 1 week after the treatment |
| Length of hospital stay | The duration of hospital stay after treatment. | 1 month after the treatment |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |