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

NCT ID: NCT05807022

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2024-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous or transbronchial argon-helium cryoablation

Group Type: EXPERIMENTAL

Percutaneous or transbronchial argon-helium cryoablation

Intervention Type: PROCEDURE

The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.

Interventions

Percutaneous or transbronchial argon-helium cryoablation

The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mingming Deng, MD

Role: CONTACT

isdeng1017@163.com

86 18801336854

Other Identifiers

2022-NHLHCRF-LX-01-0202-5

Identifier Type: -

Identifier Source: org_study_id