A Clinical Study of the Cryoablation Technique for Peripheral Lung Malignancies

Official title

A Clinical Study on Verifying the Cryoablation Technique for Peripheral Lung Malignancies Under Bronchoscopy Guidance

Overview

To assess the safety and effectiveness of bronchoscopy-guided cryoablation with cold verification for peripheral lung malignancies.

Interventions

• Procedure cryoablation
  Lung cancer patients undergo treatment for peripheral malignant lung tumors using cryoablation technology under the guidance of bronchoscopy.

Primary outcome measures

• Complete Ablation Rate [Time frame: 6 months after biopsy]

Eligibility criteria

Inclusion criteria

• (1) Age ≥ 18 years, with no gender restrictions; (2) Diagnosed as having peripheral lung cancer, with the maximum diameter of the tumor being ≤ 3 cm and the number of tumors being ≤ 3; (3) The lesion intended for ablation is evaluated as feasible for bronchoscopy-guided cryoablation therapy; (4) The subject refuses or is deemed unsuitable for radiotherapy/chemotherapy, or has no response to previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy; (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment and signs the informed consent form.

Exclusion criteria

• (1) Diffuse lesions in both lungs where ablation therapy fails to improve the condition; (2) Examinations within one month prior to the operation reveal the presence of hilar lymph node metastasis or extrapulmonary metastasis (except for cases where extrapulmonary metastasis has been controlled through local treatment); (3) Existence of contraindications for bronchoscopy, or inability of the patient to tolerate or cooperate with bronchoscopy; (4) Severe bleeding tendencies or uncorrectable coagulation dysfunctions (prothrombin time > 18 seconds, prothrombin activity < 40%); (5) Platelet count < 70×109/L, or discontinuation of anticoagulant and/or antiplatelet drugs less than one week before ablation (except for the prophylactic use of low-molecular-weight heparin before the operation); (6) Severe impairment of lung function with a maximum ventilation volume < 40%; (7) Concurrent presence of other tumors with extensive metastasis and an expected survival period of less than 3 months; (8) Poor overall condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe dysfunction of important organs, severe anemia and short-term uncorrectable nutritional and metabolic disorders; (9) Eastern Cooperative Oncology Group (ECOG) performance status score > 2; (10) The lesion to be ablated has received radiotherapy within the past 6 months; (11) Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection history (known positive for HIV1/2 antibodies), or other active infections that are judged by the researcher to potentially affect the patient's treatment; (12) Accompanied by epilepsy, history of mental illness or cognitive impairment; (13) Pregnant or lactating women, as well as male or female patients who plan to have children or become pregnant during the trial; (14) Participation in any other clinical trials within 3 months before signing the informed consent (excluding non-interventional studies); (15) Other circumstances deemed by the researcher as inappropriate for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Nakaji H, Niimi A, Matsuoka H, Iwata T, Cui S, Matsumoto H, Ito I, Oguma T, Otsuka K, Takeda T, Inoue H, Tajiri T, Nagasaki T, Kanemitsu Y, Chin K, Mishima M. Airway remodeling associated with cough hypersensitivity as a consequence of persistent cough: An experimental study. Respir Investig. 2016 Nov;54(6):419-427. doi: 10.1016/j.resinv.2016.06.005. Epub 2016 Jul 31. PMID 27886853

Identifiers

NCT: NCT06832969 · cryobiopsy-lung-cancer

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗