Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
Recruiting · NCT06572540 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiayuan Sun
View the official record on ClinicalTrials.gov →Interventions studied
Transbronchial cryoablationTransthoracic cryoablation
What this trial is about
The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
5 locations listed.
- The First Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, China
- Henan Provincial People's Hospital - Zhengzhou, Henan, China
- Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, 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