Lung Cancer
Conditions
Brief summary
The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. The main question it aims to answer are:Evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation. Participants will undergo percutaneous or transbronchial argon-helium cryoablation.
Interventions
PROCEDUREPercutaneous or transbronchial argon-helium cryoablation
The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Primary or metastatic lung cancer with definite pathological diagnosis * Not suitable for thoracotomy due to serious or serious lung or systemic diseases * Peripheral lung cancer involves pleura and chest wall, and cannot be completely removed after surgery * There are indications for surgical resection, but the patient refuses to operate * Single tumor, maximum diameter ≤ 5cm * Or the number of tumors ≤ 3 and the maximum diameter ≤ 3cm * ECOG-PS score ≤ 2 * The expected survival period is more than three months * Those who have not participated in other clinical verifications within 3 months * Subjects voluntarily signed the informed consent form
Exclusion criteria
* Serious cardio-cerebral disease or other mental diseases * Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis * Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae * Have a history of immunodeficiency, including HIV test (enzyme-linked immunosorbent assay and Western blotting) positive * Chemotherapy, radiotherapy, interventional therapy, ablation and surgical treatment within 30 days before surgical treatment * There is a tendency to severe bleeding, and the platelet is less than 50 × 109/L and severe disorder of coagulation function * Coagulation index (PT, TT, APTT)\>2.5 times of the upper normal limit * Malignant pleural effusion on the same side of the ablation focus was not well controlled * Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorder * Those who have extensive extrapulmonary metastasis and are not suitable for ablation treatment * Those who often use sedatives, sleeping pills, tranquilizers or other addictive drugs * Pregnant or lactating women * Those who can not judge the curative effect * Other conditions determined by the researcher to be unsuitable for the group, such as inability to tolerate cryoablation, difficulty in follow-up, and other serious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate and effective rate of target lesions | during the operation of argon-helium cryoablation | Enhanced imaging examination (CT, MRI or color Doppler ultrasound) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the iceball coverage rate during the procedure | during the procedure | CT |
| Subjects' tolerance of the procedure | 1 week after the operation of argon-helium cryoablation | questionnaire |
| the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score | 4 weeks(±7d) after the operation of argon-helium cryoablation | ECOG-PS questionnaire |
| To evaluate the operational performance of argon-helium cryoablation | during the procedure | questionnaire |
Contacts
Primary ContactMingming Deng, MD
Outcome results
None listed