Lung malignancies
Conditions
Interventions
NA:NA
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Diagnosed with primary peripheral lung cancer, with preoperative staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primaries); or metastatic lung tumor, with the primary lesion completely resected and the maximum diameter of the tumor <= 3 cm and the number <= 3; 3. The lesion to be ablated is assessed to be feasible for bronchoscopy-guided cryoablation therapy; 4. The lesion to be ablated was assessed to be unsuitable for surgery or refused surgery and radiotherapy, agreed to receive initial ablation therapy and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diffuse lesions in both lungs that cannot be improved by ablation therapy; 2. The presence of hilar lymph node metastases or extrapulmonary metastases on examination within 1 month prior to the procedure (except for those extrapulmonary metastases that are controlled by local treatment); 3. Those with contraindications to bronchoscopy, or those who cannot tolerate or have difficulty cooperating with bronchoscopy; 4. with severe bleeding tendency, uncorrectable coagulation dysfunction (prothrombin time >18 s, prothrombin activity 2 (see Annex 1 for details); 10. The proposed ablation site has received radiotherapy within the previous 6 months; 11. Presence of active hepatitis B, active hepatitis C, history of human immunodeficiency virus (HIV) infection (known to be HIV1/2 antibody positive) or other active infection that, in the judgment of the investigator, may affect the patient's access to treatment; 12. Persons with a history of concomitant epilepsy, psychosis, or cognitive impairment; 13. Pregnant and lactating women, and male or female patients who plan to have children or become pregnant during the trial; 14. Participation in any other clinical trial (except non-interventional studies) within 3 months prior to signing the informed consent form; 15. Other circumstances that the investigator considers inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of technology implementation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency of technology implementation;Disease control rate;Instrument operability evaluation;Safety evaluation of device use;Evaluation of physical condition; | — |
Countries
China
Contacts
Public ContactJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed