lung carcinoma
Conditions
Interventions
Case series:combined cryoablation and thermal ablation
Sponsors
Beijing Cacer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All selected subjects must meet the following relevant conditions: 1. the patient or legal representative voluntarily participate, and signing the patient's informed consent form; 2. patients aged 18-80 years of age (subject to the date of signing the informed consent form); 3. patients with primary or secondary solid tumors (lung cancer) who have been clinically diagnosed, and the lesions can be measured, requiring minimally invasive surgery; 4. the patient cannot tolerate surgical resection due to poor cardiopulmonary function or advanced age; 5. refused surgical resection; 6. ECOG-PS score is 2 or less; 7. expected lifetime more than three months; 8. people who can correctly describe and are willing to participate in follow-up survey; Primary lung cancer and metastatic lung cancer; 9. for primary lung cancer to preoperative; 10. primary lung cancer people who have been diagnosed by cytology or histological pathology diagnosis; 11. have plenty of organ function, which can meet the following conditions: Blood routine: white blood cells=3.0×109/L, neutrophils=1.5×10^9/L, platelets=100×10^9/L, hemoglobin=9.0g/dL. Liver function: total bilirubin=1.5×ULN; ALT/AST =2.5×ULN without hepatic metastasis; ALT/AST=5×ULN for liver metastasis. Coagulation function: International normalized ratio (INR)=1.5×ULN, and activated partial thromboplastin time (APTT)=1.5×ULN; (patients who are receiving anticoagulant therapy, take anticoagulant drugs such as aspirin, warfarin, clopidogrel, etc., it is necessary to stop the drug for at least 5-7 days in principle. The researchers judge that INR and APTT are safe and effective within the scope of treatment.) Renal function: serum creatinine=1.5×ULN. Curative ablation treatment: 12. single lesions recur after other local treatments (eg surgical resection, conformal radiotherapy, local ablation, etc.); 13. oligometastasis in lung after primary lung cancer surgery or after radiotherapy; 14. single lung (various causes of lung deficiency on various sides); 15. multiple primary lung cancer, and the number of double lung tumors is =3. The maximum diameter of the tumor is =5cm, and there is no metastatic lesion in other parts. Palliative ablation treatment; 16. for patients who do not reach the curative ablation conditions, in order to minimize tumor burden, alleviate the symptoms caused by tumors and improve the quality of life, the indications for palliative ablation therapy can be relaxed compared with curative ablation. Such as tumor maximum diameter >5 cm or unilateral lung lesions>3 (bilateral lung>5) (multi-needle, multi-point or multiple treatment, or combined with other treatments).
Exclusion criteria
Exclusion criteria: If find one of the following relative conditions, the subject will not be able to participate in the clinical study: 1. There are traumatic injuries in the chest and abdomen that can cause surgical infection; 2. patients with severe infections and severe heart and brain diseases; 3. have a history of immunodeficiency, including HIV testing positive (enzyme-linked immunosorbent assay and Western blotting); 4. pregnant or lactating women; 5. similar minimally invasive surgery was performed within 1 month; 6. those who have undergone radiotherapy or chemotherapy within 1 month; 7. patients who are considered unsuitable for this clinical study by the researcher. Primary lung cancer and metastatic lung cancer: 1. patients with previous severe pulmonary dysfunction, pulmonary fibrosis, pulmonary dysfunction, and multiple pulmonary bullae; 2. malignant pleural effusion on the same side of ablative lesions are not well controlled; 3. patients with diffuse or extensive extrapulmonary metastases in both lung lesions; 4. extensive pleural metastasis; 5. lung lumps, puncture and freezing cannot avoid large blood vessels or segmental bronchus, postoperatively complicated with major bleeding or respiratory failure; 6. the distance between the lesion and the hilar and large blood vessels and the main bronchus is in principle less than 1 cm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local efficiency after tumor ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local effective control rate after tumor ablation treatment at 3 months and 6 months after cryoablation;Local recurrence rate;Quality of life score;Overall survival;progression-free survival; | — |
Countries
China
Contacts
Public ContactXu Zhu, Yinghua Zou
Beijing Cacer Hospital
Outcome results
None listed