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Trial Title:
Transthoracic vs Transbronchial Ablation for Lung Cancer
NCT ID:
NCT06503744
Condition:
Lung Cancer Stage IA
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
ablation
Description:
ablation
Arm group label:
Transbronchial ablation
Arm group label:
Transthoracic ablation
Summary:
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.
Detailed description:
Ablation therapy has been widely used in the treatment of lung cancer and traditionally
performed by CT-guided transthoracic puncture. In recent years, with the development of
navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral
lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective
randomized controlled trials to verify its near-term efficacy and safety, as well as its
long-term efficacy. This study was designed as a prospective randomised controlled trial
with 110 patients expected to participate in the study, randomized in a 1:1 ratio to
CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study
endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study
endpoints were success rate of technique implementation, complete ablation rate at 12
months post-procedure, local control rate at 1, 2 and 3 years post-procedure,
progression-free survival, overall survival and safety.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiayuan Sun, PhD
Phone:
+86-021-22200000
Phone ext:
1511
Email:
jysun1976@163.com
Start date:
January 4, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503744
