RecruitingNot ApplicableNCT06848881
Cryoablation vs Thoracoscopic Surgery for GGN
Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study
Sponsor
Shanghai Chest Hospital
Enrollment
160 participants
Start Date
Apr 20, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Patients ≥ 18 years old.
- 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.
- 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.
- No lymph node, pulmonary, or distant metastasis to other organs.
- After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
- Unsuitable for radiation therapy or refusal of radiation therapy.
- Willing to participate in this clinical study and sign the informed consent form.
Exclusion Criteria12
- Patients in poor general condition, with ECOG physical fitness score >2, unable to tolerate surgery or ablation therapy, or with relevant contraindications.
- Patients who have previously received other treatments for pulmonary GGNs.
- Patients with poor compliance.
- Severe heart, lung, kidney, brain, or other vital organ diseases.
- Active bacterial or fungal infections.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Women during pregnancy or breast-feeding.
- History of radiation therapy.
- Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment.
- Contraindications to general anesthesia.
- Expected survival time < 6 months.
- The researcher believes that it is not suitable for inclusion.
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06848881