Pulmonary nodule
Conditions
Interventions
Transforaminal group :Transbronchoscopic lung nodule ablation
Sponsors
The Fourth Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 <= age <= 80 years old, gender is not limited; 2.Subjects to be ablated for malignant or suspected malignant lung nodules, including stage IA primary peripheral non-small cell lung cancer or intrapulmonary solitary metastases or lung nodules with malignant tendency; 3.Subjects with a lung nodule requiring ablation that is = 8 mm in diameter; 4.Subject refuses or is deemed unsuitable for surgical resection or stereotactic radiation therapy; 5.The subject has a prior surgical history of pulmonary malignancy and cannot tolerate reoperation; 6.The patient's wishes are strong and enrollment is deemed appropriate by multidisciplinary consultation or departmental discussion; 7.The subject or his/her legal representative is able to understand the purpose of the study, demonstrates sufficient compliance with the study protocol, and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with an Eastern Cooperative Oncology Group (ECOG) physical status score of >=3; 2.Subjects who have received chemotherapy, radiotherapy, immunotherapy, targeted agents, surgery, or other minimally invasive methods for the treatment of tumors or lung nodules within 30 days prior to ablation and within 30 days of anticipated ablation; 3.Subjects with severe pulmonary fibrosis and pulmonary hypertension; 4.Subjects with the presence of a poorly controlled pleural effusion; 5.Subjects who are impaired in consciousness or unable to cooperate with treatment; 6.Subjects with severe bleeding tendency and obvious blood abnormalities that cannot be corrected within a short period of time for coagulation dysfunction (platelets 18s, and prothrombin activity 38.5°C) , etc.) in subjects; 9.Subjects with expected survival < 6 months; 10.Pregnant and lactating women; 11.Subjects participating in other clinical trials 3 months prior to study treatment and during the follow-up period; 12.Subjects who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete ablation rate of pulmonary nodules; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAE (Serious Adverse Event) incidence rate; | — |
Countries
China
Contacts
Public ContactJunhong Jiang
The Fourth Affiliated Hospital of Soochow University
Outcome results
None listed