Status:
RECRUITING
Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
Lead Sponsor:
Jiayuan Sun
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06572540
Start Date
September 1 2024
End Date
December 31 2028
Last Update
July 18 2025
Active Locations (5)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 462000
3
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
4
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041