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

China-Japan Friendship Hospital

Status

Not yet enrolling

Conditions

Lung Cancer

Treatments

Procedure: Percutaneous or transbronchial argon-helium cryoablation

Study type

Interventional

Funder types

Other

Identifiers

NCT05807022

2022-NHLHCRF-LX-01-0202-5

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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