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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Percutaneous or transbronchial argon-helium cryoablation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingming Deng, MD; Phone Number: 86 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous or transbronchial argon-helium cryoablation	Procedure: Percutaneous or transbronchial argon-helium cryoablation; The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0202-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No