Ground-Glass Opacity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECryoablation
The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.
PROCEDUREThoracoscopic Surgery
The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years old. 2. The size of the GGN is 8-20mm (with less than 25% solid component), and the number of nodules requiring treatment in the short term is less than 3. 3. Pathological confirmation of the GGN as non-small cell lung cancer; or progression of the GGN during at least 3 months of follow-up, including enlargement of the largest diameter, increase in solid component, or the appearance of a significant solid component in a previously pure GGN, with multidisciplinary discussion (including radiology, thoracic surgery, and pulmonology) suggesting malignancy. 4. No lymph node, pulmonary, or distant metastasis to other organs. 5. After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures. 6. Unsuitable for radiation therapy or refusal of radiation therapy. 7. Willing to participate in this clinical study and sign the informed consent form.
Exclusion criteria
1. Patients in poor general condition, with ECOG physical fitness score \>2, unable to tolerate surgery or ablation therapy, or with relevant contraindications. 2. Patients who have previously received other treatments for pulmonary GGNs. 3. Patients with poor compliance. 4. Severe heart, lung, kidney, brain, or other vital organ diseases. 5. Active bacterial or fungal infections. 6. Simultaneous or metachronous (within the past 5 years) double cancers. 7. Women during pregnancy or breast-feeding. 8. History of radiation therapy. 9. Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment. 10. Contraindications to general anesthesia. 11. Expected survival time \< 6 months. 12. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year disease-free survival | Up to 2 years | Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-month mortality rate | 1 month after the treatment | The proportion of patients who die within one month after treatment. |
| Overall survival | Up to 2 years, 5years | Defined as the time from enrollment to death from any cause, or to the last contact with surviving patients. |
| 5-year disease-free survival | Up to 5 years | Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause. |
| Local recurrence rate | Up to 5 years | The proportion of patients who experience disease recurrence at the original treatment site. |
| VATS/ cryoablation completion rate | immediately after the treatment | The proportion of patients in whom VATS or cryoablation is successfully completed. |
| Forced Expiratory Volume in 1 Second (FEV1) | 3 months after the treatment | The maximum volume of air exhaled in the first second during a forced expiration following maximal inhalation. |
| Forced Vital Capacity (FVC) | 3 months after the treatment | The total volume of air exhaled as forcefully and completely as possible after maximal inhalation. |
| Adverse events and serious adverse events | 3 months after the treatment | 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. |
| Quality of life assessment | 1 week after the treatment | Pain scores. |
| Length of hospital stay | 1 month after the treatment | The duration of hospital stay after treatment. |
Countries
China
Contacts
CONTACTJiayuan Sun, MD, PhD
STUDY_DIRECTORJiayuan Sun, MD, PhD
Shanghai Chest Hospital
Outcome results
None listed