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

NCT05807022 — Not applicable, Unknown, 60 participants, China-Japan Friendship Hospital

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RegistryNCT05807022
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment60 (Estimated)
SponsorChina-Japan Friendship Hospital (Other)
ConditionsLung Cancer
InterventionsPercutaneous or transbronchial argon-helium cryoablation (Procedure)
Datesstart 2023-03-30 (estimated), primary completion 2024-12-01 (estimated), completion 2024-12-31 (estimated), first posted 2023-04-10, last updated 2023-04-10

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Percutaneous or transbronchial argon-helium cryoablationExperimentalProcedure: Percutaneous or transbronchial argon-helium cryoablation
  • Percutaneous or transbronchial argon-helium cryoablation (Procedure): The participants would undergo Percutaneous or transbronchial argon-helium cryoablation.

+Outcome measures

Primary outcomes

  • 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)
  • 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)
  • 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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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