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Study on the safety and efficacy of comparative microwave ablation, cryoablation system and combined cryoablation and thermal ablation treatment system in the treatment of peripheral pulmonary nodules

Study on the safety and efficacy of single center comparative microwave ablation, cryoablation system and combined cryoablation and thermal ablation treatment system in the treatment of peripheral pulmonary nodules

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057885
Enrollment
Unknown
Registered
2022-03-20
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral pulmonary nodule

Interventions

Plasma cryoablation group:plasma cryoablation
Combined cryoablation and thermal ablation group:combined cryoablation and thermal ablation

Sponsors

Tianjin Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years; 2. The main lesions planned to be ablated are confirmed by pathology, and other lesions planned to be ablated are confirmed by pathology or clinically assessed as primary non-small cell lung cancer or pulmonary metastatic tumor (the primary disease of the subjects with pulmonary metastatic tumor is well controlled); In situ recurrence of lung cancer; 3. Number of unilateral lung lesions: = 3 (except multiple primary lung cancer); 4. The size of each lung lesion: = 3cm; 5. Subjects refused surgery or could not tolerate surgery according to clinical evaluation; 6. Subjects refuse or are considered unsuitable for radiotherapy/chemotherapy, or have no reaction to previous radiotherapy/chemotherapy, or have disease progression after radiotherapy/chemotherapy; 7. According to the evaluation of the investigator, it is feasible to reach the target lesion through percutaneous puncture and perform ablation; 8. Subjects in the Eastern Tumor Cooperation Group (ECOG) with physical condition score: = 3; 9. The subject agreed to receive local ablation for pulmonary lesions.

Exclusion criteria

Exclusion criteria: 1. Subjects with severe bleeding tendency and irreversible coagulation disorder; Or before ablation subjects who stopped anticoagulation treatment and/or antiplatelet drugs for less than 7 days; 2. Subjects who found intrathoracic lymph node or extrapulmonary metastasis within 1 month of preoperative examination (except extrapulmonary metastasis controlled by local treatment); 3. The ablation focus is planned to receive radiotherapy in the past 6 months; 4. Subjects with high-risk diseases; 5. The nearest distance between tumor and trachea, main bronchus, esophagus, aortic arch branch, main pulmonary artery, left and right pulmonary arteries and heart is less than 2cm; 6. Subjects who have participated in or are participating in other clinical studies in the past 30 days 7. Subjects who were pregnant or had a pregnancy plan during the study; 8. Other subjects identified by the researcher to be excluded.

Design outcomes

Primary

MeasureTime frame
local control rate;

Secondary

MeasureTime frame
progression-free survival (PFS);overall survival(OS);cancer-specific survival;

Countries

China

Contacts

Public ContactDaqiang Sun

Tianjin Chest Hospital

sdqmd@163.com+86 13034337758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026