Clinical trial NCT05807022: Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
Official title: Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete response rate and effective rate of target lesions
timeFrame: during the operation of argon-helium cryoablation
measure: Complete response rate and effective rate of target lesions
timeFrame: 1 week after the operation of argon-helium cryoablation
measure: Complete response rate and effective rate of target lesions
timeFrame: 4 weeks(±7d) after the operation of argon-helium cryoablation
Secondary outcomes:
measure: the iceball coverage rate during the procedure
timeFrame: during the procedure
measure: Subjects' tolerance of the procedure
timeFrame: 1 week after the operation of argon-helium cryoablation
measure: the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score
timeFrame: 4 weeks(±7d) after the operation of argon-helium cryoablation
measure: To evaluate the operational performance of argon-helium cryoablation
timeFrame: during the procedure
Other outcomes:
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Study officials:
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