Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiayuan Sun
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transthoracic cryoablation
DeviceTransthoracic cryoablation will be performed under the guidance of CT.
Transbronchial cryoablation
DeviceTransbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Transthoracic cryoablationActive comparator 1 intervention
Group B: Transbronchial cryoablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete ablation rate at 12 months
Twelve months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation.
Time frame
Twelve months post-ablationSecondary outcomes
1
Technical success rate
It is defined as the number of lesions for which the ablation needle reached the location of the lesion and was successfully ablated as a proportion of the total number of lesions to be ablated, as assessed by immediate post-ablation imaging
Time frame
Immediately after Each Operation2
Complete ablation rate at 6 months
Six months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation.
Time frame
Six months post-ablation3
Local control rates at 1, 2 and 3 years postoperatively
The number of lesions with complete and incomplete ablation at 1, 2, and 3 years after ablation treatment as a proportion of the number of all ablation-treated lesions.
Time frame
12, 24, 36 monthspost-ablation4
Progression-free survival (PFS)
PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.
Time frame
From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiayuan Sun
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
Source ClinicalTrials.gov