Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
Not Applicable
Not yet recruiting
- Conditions
- Lung Cancer
- Interventions
- Procedure: Percutaneous or transbronchial argon-helium cryoablation
- Registration Number
- NCT05807022
- Lead Sponsor
- China-Japan Friendship Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Percutaneous or transbronchial argon-helium cryoablation Percutaneous or transbronchial argon-helium cryoablation -
- Primary Outcome Measures
Name Time Method Complete response rate and effective rate of target lesions 4 weeks(±7d) after the operation of argon-helium cryoablation Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
- Secondary Outcome Measures
Name Time Method Subjects' tolerance of the procedure 1 week after the operation of argon-helium cryoablation questionnaire
To evaluate the operational performance of argon-helium cryoablation during the procedure questionnaire
the iceball coverage rate during the procedure during the procedure CT
the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 4 weeks(±7d) after the operation of argon-helium cryoablation ECOG-PS questionnaire