Transbronchial Ablation for Peripheral Lung Tumor

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Procedure: Radiofrequency ablation; Procedure: Microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02972177

SHCHE201603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Radiofrequency ablation group

Experimental group

Description:

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.

Treatment:

Procedure: Radiofrequency ablation

Microwave ablation group

Experimental group

Description:

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.

Treatment:

Procedure: Microwave ablation