Early-stage pulmonary nodules (including pulmonary ground-glass nodules, small pulmonary nodules), early malignant pulmonary nodules/preneoplastic lesions undergoing minimally invasive ablation therapy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age older than 18 years; 2.Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary); 3.The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation; 4.Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with platelets 38.5°C; 4.Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term; 5.Those with poorly controlled malignant pleural effusions; 6.Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5~7d before ablation; 7.Eastern Cooperative Oncology Group (ECOG) score > 2; 8.Combination with other tumors with extensive metastases and an expected survival of <6 months; 9.Patients with episodic psychosis; 10.Pregnant women, or patients with pregnancy plan during the study period; 11.Have participated or are participating in other clinical studies within 30 days; 12.Any other condition that the investigator considers inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month Complete Ablation Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Needle Placement Accuracy;Postoperative Hospital Stay;Quality of Life Score (SF-36/EQ-5D);Complication Rate;12-month Local Control Rate;Procedure Duration; | — |
Countries
China
Contacts
The Affiliated Hospital of Xuzhou Medical University