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

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

NCT ID: NCT05807022

Condition: Lung Cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Percutaneous or transbronchial argon-helium cryoablation
Description: The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.
Arm group label: Percutaneous or transbronchial argon-helium cryoablation

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Start date: March 30, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: China-Japan Friendship Hospital
Agency class: Other

Source: China-Japan Friendship Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05807022