Cryoablation vs Thoracoscopic Surgery for GGN

Not Applicable

Not yet recruiting

• Conditions: Ground-Glass Opacity

• Registration Number: NCT06848881
• Lead Sponsor: Shanghai Chest Hospital

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 was designed as a prospective, randomized controlled trial, with 160 patients expected to be enrolled in the study, randomized in a 1:1 ratio to cryoablation and thoracoscopic surgery treatment groups. 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 Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-22
• Study First Posted: 2025-02-27
• Status Verified: 2025-04
• Study Start: 2025-04-15
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22
• Primary Completion: 2030-04-15
• Study Completion: 2030-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Patients ≥ 18 years old.
2. The size of the GGN was 6-20mm (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 refuses 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 prior lung surgery or 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Forced Vital Capacity (FVC)	3 months after the treatment	The total volume of air exhaled as forcefully and completely as possible after maximal inhalation.
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.
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.

Trial Locations

Locations (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China