Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-04-15
2030-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cryoablation group
Ground-glass nodules were treated using cryoprobe by bronchoscope.
Cryoablation
The eligible patient will be randomized to cryoablation group to receive cryoablation.
Thoracoscopic Surgery group
Ground-glass nodules were treated by video-assisted thoracoscopic surgery (VATS). Based on the location of the GGN, select the appropriate surgical resection range (wedge resection, segmentectomy, lobectomy, or combined segmentectomy).
Thoracoscopic Surgery
The eligible patient will be randomized to thoracoscopic surgery group to receive surgery.
Interventions
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Cryoablation
The eligible patient will be randomized to cryoablation group to receive cryoablation.
Thoracoscopic Surgery
The eligible patient will be randomized to thoracoscopic surgery group to receive surgery.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Respiratory Endoscopy
Principal Investigators
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Jiayuan Sun, MD, PhD
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHCHE202501
Identifier Type: -
Identifier Source: org_study_id
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