Clinical trial NCT06848881: Cryoablation vs Thoracoscopic Surgery for GGN
Official title: Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ground-Glass Opacity
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 2-year disease-free survival
timeFrame: Up to 2 years
Secondary outcomes:
measure: 1-month mortality rate
timeFrame: 1 month after the treatment
measure: Overall survival
timeFrame: Up to 2 years, 5years
measure: 5-year disease-free survival
timeFrame: Up to 5 years
measure: Local recurrence rate
timeFrame: Up to 5 years
measure: VATS/ cryoablation completion rate
timeFrame: immediately after the treatment
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 3 months after the treatment
measure: Forced Vital Capacity (FVC)
timeFrame: 3 months after the treatment
measure: Adverse events and serious adverse events
timeFrame: 3 months after the treatment
measure: Quality of life assessment
timeFrame: 1 week after the treatment
measure: Length of hospital stay
timeFrame: 1 month after the treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References: