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

• Sponsor: China-Japan Friendship Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05807022
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Anticipated Duration (Months): 21.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: Percutaneous or transbronchial argon-helium cryoablation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Complete response rate and effective rate of target lesions [during the operation of argon-helium cryoablation]

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

2. Complete response rate and effective rate of target lesions [1 week after the operation of argon-helium cryoablation]

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

3. Complete response rate and effective rate of target lesions [4 weeks(±7d) after the operation of argon-helium cryoablation]

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

Secondary Outcome Measures

1. the iceball coverage rate during the procedure [during the procedure]

   CT

2. Subjects' tolerance of the procedure [1 week after the operation of argon-helium cryoablation]

   questionnaire

3. the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score [4 weeks(±7d) after the operation of argon-helium cryoablation]

   ECOG-PS questionnaire

4. To evaluate the operational performance of argon-helium cryoablation [during the procedure]

   questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gang Hou, Principal Investigator, China-Japan Friendship Hospital
• ClinicalTrials.gov Identifier: NCT05807022
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0202-5
• First Posted: Apr 10, 2023
• Last Update Posted: Apr 10, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 10, 2023