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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05807022
• Other study ID #: 2022-NHLHCRF-LX-01-0202-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate and effective rate of target lesions	Enhanced imaging examination (CT, MRI or color Doppler ultrasound)	during the operation of argon-helium cryoablation
Primary	Complete response rate and effective rate of target lesions	Enhanced imaging examination (CT, MRI or color Doppler ultrasound)	1 week after the operation of argon-helium cryoablation
Primary	Complete response rate and effective rate of target lesions	Enhanced imaging examination (CT, MRI or color Doppler ultrasound)	4 weeks(±7d) after the operation of argon-helium cryoablation
Secondary	the iceball coverage rate during the procedure	CT	during the procedure
Secondary	Subjects' tolerance of the procedure	questionnaire	1 week after the operation of argon-helium cryoablation
Secondary	the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score	ECOG-PS questionnaire	4 weeks(±7d) after the operation of argon-helium cryoablation
Secondary	To evaluate the operational performance of argon-helium cryoablation	questionnaire	during the procedure