Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

Recruiting now · Not applicable

Conditions studied: Lung Cancer

In brief

The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Key facts

Study ID

NCT06572540

Run by

Jiayuan Sun

People needed

110

Starts

2024-09-01

Expected to finish

2028-12-31

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age older than 18 years.
• Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
• The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation.
• Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.

You may not qualify if…

• Patients with platelets <70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term.
• Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
• 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.
• 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.
• Those with poorly controlled malignant pleural effusions.
• 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.
• Eastern Cooperative Oncology Group (ECOG) score >2.
• Combination with other tumors with extensive metastases and an expected survival of <6 months.
• Patients with episodic psychosis.
• Pregnant women, or patients with pregnancy plan during the study period.
• Have participated or are participating in other clinical studies within 30 days.
• Any other condition that the investigator considers inappropriate for participation in this study.

Where it is running

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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