Cryoablation vs Thoracoscopic Surgery for GGN
ConditionGround-Glass Opacity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cryoablation
Procedure/SurgeryThe eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.
Thoracoscopic Surgery
Procedure/SurgeryThe eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Cryoablation groupExperimental treatment 1 intervention
Group B: Thoracoscopic Surgery groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-year disease-free survival
Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.
Time frame
Up to 2 yearsSecondary outcomes
1
1-month mortality rate
The proportion of patients who die within one month after treatment.
Time frame
1 month after the treatment2
Overall survival
Defined as the time from enrollment to death from any cause, or to the last contact with surviving patients.
Time frame
Up to 2 years, 5years3
5-year disease-free survival
Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.
Time frame
Up to 5 years4
Local recurrence rate
The proportion of patients who experience disease recurrence at the original treatment site.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov