Transbronchial Ablation for Peripheral Lung Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study of Navigation Bronchoscopy Guided Ablation for the Treatment of Peripheral Lung Tumor

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Radiofrequency ablation
* Procedure: Microwave ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 year-old. 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. Chest CT shows the length-diameter of the tumor is more than 8mm and no more than 50mm. Patients are unsuitable for surgery assessed by multidisciplinary team and agree to the primary treatment of ablation. Patients have good compliance and sign the informed consent. Exclusion Criteria: Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications. Patients have contraindications of general anesthesia. Chest CT or bronchoscopy shows that guided and treatment instruments cannot reach the peripheral lung lesion. There are large blood vessels or important structures adjacent to peripheral lung lesion. Researchers consider the patient do not fit for the study due to other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation group<br>Patients with inoperable peripheral lung tumor will be performed transbronchial radiofrequency ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure. | Procedure: Radiofrequency ablation<br>* Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.<br>|
| Experimental: Microwave ablation group<br>Patients with inoperable peripheral lung tumor will be performed transbronchial microwave ablation with the guidance of navigation bronchoscopy. Post treatment response will be evaluated and follow up will be carried out according to the standard procedure. | Procedure: Microwave ablation<br>* Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate | Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor. | Three months after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the time of treatment to the time of disease progression or death, assessed up to 1 year | 
| Overall survival（OS） | Overall survival（OS) is evaluated after the treatment of ablation until the patient death. | From the time of treatment to the time of the patient death, assessed up to 3 years | 
| Cancer-specific survival | The cause of death is related to the patient's underlying malignancy. | From the time of treatment to the time of the patient death, assessed up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Transbronchial ablation, Radiofrequency ablation, Microwave ablation