Transbronchial Ablation for Peripheral Lung Tumor

Shanghai Chest Hospital60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Radiofrequency ablationPROCEDURE

Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.

Microwave ablationPROCEDURE

Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Local control rate

Local control rate was defined as the proportion of the complete ablation and incomplete ablation of the tumor.

Time frame: Three months after ablation

Secondary Outcomes

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, assessed up to 1 year

Overall survival（OS）

Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

Time frame: 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.

Time frame: From the time of treatment to the time of the patient death, assessed up to 3 years

Central Contacts

Jiayuan Sun, MD,PhD

CONTACT

86-021-22200000-1521 jysun1976@163.com

Data from ClinicalTrials.gov

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