Lung Cancer
Conditions
Keywords
Lung cancer, Transbronchial ablation, Radiofrequency ablation, Microwave ablation
Brief summary
The objective of the study was to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for the treatment of inoperable peripheral lung tumor.
Detailed description
The study is aimed to evaluate the efficacy and safety of navigation bronchoscopy guided transbronchial ablation for treating inoperable malignant lung tumor. The study is designed as a single-center prospective trial. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital,Shanghai Jiao Tong University, China. Patients are divided into two groups, including radiofrequency ablation group and microwave ablation group. Sixty patients are expected to be enrolled into the study with 30 patients in each group.
Interventions
PROCEDURERadiofrequency ablation
Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
PROCEDUREMicrowave ablation
Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients older than 18 year-old. 2. Patients meeting one of the following criteria: 1) patients discovered with peripheral lung lesions that have demonstrated to be lung cancer by pathology with the clinical stage no later than IIA. 2) recurrent or progressive single lesion or solitary intrapulmonary metastasis after surgery, radiotherapy, chemotherapy or other treatment.3) multiple primary lung cancer with the number of tumors no more than 5 and no metastasis. 4) pulmonary metastases with effective treatment of primary disease, the number of metastases no more than 5 and no other metastasis. 3. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm. 4. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation. 5. Patients have good compliance and sign the informed consent.
Exclusion criteria
1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. 2. Patients have contraindications of general anesthesia. 3. Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion. 4. There are large blood vessels or important structures adjacent to peripheral lung lesion. 5. Researchers consider the patient do not fit for the study due to other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control rate | Three months after ablation | Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From the time of treatment to the time of disease progression or death, assessed up to 1 year | PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death. |
| Overall survival（OS） | From the time of treatment to the time of the patient death, assessed up to 3 years | Overall survival（OS) is evaluated after the treatment of ablation until the patient death. |
| Cancer-specific survival | From the time of treatment to the time of the patient death, assessed up to 3 years | The cause of death is related to the patient's underlying malignancy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE 4.0 | From the time of treatment to the complication occured, assessed up to 1 month | Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection. |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD,PhD
Outcome results
None listed