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

China-Japan Friendship Hospital0 sites60 target enrollmentMarch 30, 2023

ConditionsLung Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: China-Japan Friendship Hospital
Enrollment: 60
Primary Endpoint: Complete response rate and effective rate of target lesions
Status: Not Yet Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China-Japan Friendship Hospital

Responsible Party

Principal Investigator

Gang Hou

Principal Investigator

China-Japan Friendship Hospital

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

Outcomes

Primary Outcomes

Complete response rate and effective rate of target lesions

Time Frame: 4 weeks(±7d) after the operation of argon-helium cryoablation

Enhanced imaging examination (CT, MRI or color Doppler ultrasound)

Secondary Outcomes

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