Transthoracic cryoablation: Transthoracic cryoablation will be performed under the guidance of CT.
Transbronchial cryoablation: Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.
Study summary
The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age older than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
3. The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation.
4. Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.
Exclusion Criteria:
1. Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term.
2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C.
4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term.
5. Those with poorly controlled malignant pleural effusions.
6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \>2.
8. Combination with other tumors with extensive metastases and an expected survival of \<6 months.
9. Patients with episodic psychosis.
10. Pregnant women, or patients with pregnancy plan during the study period.
11. Have participated or are participating in other clinical studies within 30 days.
12. Any other condition that the investigator considers inappropriate for participation in this study.
Primary outcome measure(s)
Complete ablation rate at 12 months — Twelve months post-ablation Twelve months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation.
Trial sites (5)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Not Yet Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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