Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Percutaneous or transbronchial argon-helium cryoablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous or transbronchial argon-helium cryoablation<br> | Procedure: Percutaneous or transbronchial argon-helium cryoablation<br>* The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate and effective rate of target lesions | Enhanced imaging examination (CT, MRI or color Doppler ultrasound) | during the operation of argon-helium cryoablation | 
| Complete response rate and effective rate of target lesions | Enhanced imaging examination (CT, MRI or color Doppler ultrasound) | 1 week after the operation of argon-helium cryoablation | 
| Complete response rate and effective rate of target lesions | Enhanced imaging examination (CT, MRI or color Doppler ultrasound) | 4 weeks(±7d) after the operation of argon-helium cryoablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the iceball coverage rate during the procedure | CT | during the procedure | 
| Subjects' tolerance of the procedure | questionnaire | 1 week after the operation of argon-helium cryoablation | 
| the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score | ECOG-PS questionnaire | 4 weeks(±7d) after the operation of argon-helium cryoablation | 
| To evaluate the operational performance of argon-helium cryoablation | questionnaire | during the procedure |