RecruitingNot ApplicableNCT06572540

Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

Transthoracic Versus Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer: A Prospective, Randomized Controlled Trial

Sponsor

Jiayuan Sun

Enrollment

110 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria12

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.