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

NCT05807022 | Unknown

• 1 other identifier: 2022-NHLHCRF-LX-01-0202-5
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• the iceball coverage rate during the procedure

  during the procedure

• Subjects' tolerance of the procedure

  1 week after the operation of argon-helium cryoablation

• the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score

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

• To evaluate the operational performance of argon-helium cryoablation

  during the procedure

Study Arms (1)

Percutaneous or transbronchial argon-helium cryoablation

EXPERIMENTAL

Procedure: Percutaneous or transbronchial argon-helium cryoablation

Interventions

Percutaneous or transbronchial argon-helium cryoablation PROCEDURE

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

Percutaneous or transbronchial argon-helium cryoablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Administration, Cutaneous

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 10, 2023
• Study Start: March 30, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-04