Comparing two methods of ablation for early-stage lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of two different ablation techniques—transthoracic and transbronchial—for treating early-stage peripheral lung cancer. It is designed as a prospective randomized controlled trial involving 110 patients, who will be randomly assigned to either the CT-guided or bronchoscopy-guided ablation groups. The primary endpoint is the rate of complete ablation at six months post-procedure, while secondary endpoints include long-term local control rates and overall survival. The study aims to provide robust data on the effectiveness of these two approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age greater 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 proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
4. Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

Exclusion Criteria:

1. Patients with platelets \<50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the 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 the 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 of other tumours with extensive metastases and an expected survival of \<6 months.
9. Patients with episodic psychosis.
10. Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
11. Pregnant women, or patients with a pregnancy planned during the study period.
12. Have participated or are participating in other clinical studies within the last 30 days.
13. Any other condition that the investigator considers inappropriate for participation in this study.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jiayuan Sun, PhD
• Email: jysun1976@163.com
• Phone: +86-021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.