Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

Launched by JIAYUAN SUN · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods of treating early-stage peripheral lung cancer: transthoracic cryoablation and transbronchial cryoablation. Both methods involve freezing the cancer cells to destroy them, but they do so in slightly different ways. The study aims to find out which method is more effective and safer for patients who have lung cancer that has not spread and are not candidates for surgery.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with early-stage lung cancer that meets specific criteria. They should also be unable to undergo surgery or choose not to have it. Patients will undergo an initial treatment using one of the cryoablation methods and will need to provide informed consent, meaning they agree to participate after understanding the study. It’s important to note that certain health conditions, such as severe bleeding disorders or significant heart and lung issues, may prevent someone from joining the trial. The study is not yet recruiting participants, so there will be more information available once it starts.

Gender

ALL

Eligibility criteria

• 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.