Cryoablation versus thoracoscopic surgery for ground-glass lung nodules

Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study

This trial will test whether cryoablation or minimally invasive thoracoscopic surgery works better and is safer for adults with 8–20 mm ground-glass lung nodules suspected to be early-stage cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06848881 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized study enrolling about 160 adults with pulmonary ground-glass nodules (8–20 mm, ≤25% solid component) who are candidates for either procedure. Participants choose between image-guided percutaneous cryoablation or video-assisted thoracoscopic surgery (VATS) and are followed for outcomes including 2-year disease-free survival, overall survival, local recurrence, procedure completion rates, and safety. The primary endpoint is 2-year disease-free survival, and secondary endpoints include 1-month mortality, 5-year disease-free survival, local recurrence, completion rates, and complications. Patients receive multidisciplinary evaluation and are treated and followed at Shanghai Chest Hospital.

Who should consider this trial

Good fit: Adults (≥18) with one to three pulmonary GGNs sized 8–20 mm with ≤25% solid component, pathologic confirmation or clear radiologic progression, no metastasis, and who can tolerate either procedure are ideal candidates.

Not a fit: Patients with larger or more solid nodules, metastatic disease, poor overall health, or who cannot tolerate or refuse both procedures are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, cryoablation could offer a less invasive treatment with comparable disease control and fewer complications than thoracoscopic surgery for selected patients.

How similar studies have performed: Image-guided ablation, including cryoablation, is supported by guideline recommendations and has shown favorable safety in prior series, but direct head-to-head noninferiority evidence versus VATS for GGNs is currently lacking.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiayuan Sun, MD, PhD

Conditions Ground-Glass Opacity