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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.
The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITING2-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.
Time frame: Up to 2 years
1-month mortality rate
The proportion of patients who die within one month after treatment.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Local recurrence rate
The proportion of patients who experience disease recurrence at the original treatment site.
Time frame: Up to 5 years
VATS/ cryoablation completion rate
The proportion of patients in whom VATS or cryoablation is successfully completed.
Time frame: 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.
Time frame: 3 months after the treatment
Forced Vital Capacity (FVC)
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The total volume of air exhaled as forcefully and completely as possible after maximal inhalation.
Time frame: 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.
Time frame: 3 months after the treatment
Quality of life assessment
Pain scores.
Time frame: 1 week after the treatment
Length of hospital stay
The duration of hospital stay after treatment.
Time frame: 1 month after the treatment