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Transthoracic vs Transbronchial Radiofrequency Ablation for Lung Cancer

ConditionLung Cancer Stage IA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater 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 proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.

Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

Disqualifiers

Patients with platelets <50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the 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 the short term.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ablation

    Procedure/Surgery

    ablation

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Transthoracic ablationActive comparator 1 intervention
Group B: Transbronchial ablationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete ablation rate at 6 months post-procedure

This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions.

Time frame
Up to 6 months

Secondary outcomes

1

Success rate of technique implementation

Defined as the number of lesions reached by the ablation needle and successfully treated by ablation as a proportion of the total number of lesions to be ablated, as assessed by imaging immediately after ablation.

Time frame
Immediate postoperative
2

Complete ablation rate at 12 months post-procedure

This refers to the number of lesions completely ablated 12 months after ablative treatment as a proportion of the total number of ablative treated lesions.

Time frame
Up to 12 months
3

Local control rate at 1, 2 and 3 years post-procedure

This refers to the number of completely ablated and incompletely ablated lesions at 1, 2 and 3 years after ablative treatment as a proportion of the total number of ablative treated lesions.

Time frame
Up to 36 months
4

Progression-free survival

Refers to the duration between the subject's study procedure and the first occurrence of disease progression or death from any cause, recorded through follow-up for up to 3 years.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Sir Run Run Shaw Hospital

Collaborator

Beijing Chao Yang Hospital

Collaborator

Source ClinicalTrials.gov
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