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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
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The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transbronchial group | Experimental | Subjects receive bronchoscopy-guided RFA and undergo follow-up. |
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| Transthoracic group | Experimental | Subjects receive CT-guided RFA and undergo follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system | Device | Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate at 6 months after ablation | It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation. | Immediately after ablation |
| Complete ablation rate 12 months after ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | 86-021-22200000 | 1511 | xkyyjysun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system | Device | Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT. |
|
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
| 12 months |
| Local control rate at 1 year, 2 years and 3 years after ablation | It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation. | 1 year, 2 years and 3years |
| Progression free survival (PFS) | It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject. | 3 years |
| Overall survival (OS) | It is defined as the total time from the ablation to the death of the subject. | 3 years |
| Safety | To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study. | 12 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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