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This is a prospective, single-arm, open-label clinical study. The primary study objective is to evaluate the feasibility of synchronous biopsy and radiofrequency ablation for pulmonary nodules under robotic-assisted bronchoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with clinically suspected malignant pulmonary nodules requiring diagnosis and treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules | Procedure | All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. All procedures are performed under the guidance of shape-sensing robotic-assisted bronchoscopy integrated with mobile cone-beam computed tomography. Cyobiopsy is performed first using the 1.1-mm cryoprobe, followed by intraoperative frozen section for rapid diagnosis. If malignancy is confirmed, radiofrequency ablation is conducted in the same procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate (at the lesion level) | The proportion of lesions with a definite malignant diagnosis by synchronous biopsy and effective ablation (with postoperative immediate imaging indicating that the ablation range is at least 5 mm larger than the boundary of the target lesion) among the lesions ultimately diagnosed as malignant. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy diagnostic yield (at the lesion level) | The proportion of lesions with a definite malignant or specific benign diagnosis by biopsy among all the lesions undergoing biopsy, evaluated by the pathological diagnosis. | 6 months |
| Sensitivity of malignancy (at the lesion level) |
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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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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The proportion of lesions with a definite malignant diagnosis by biopsy among all the lesions confirmed to be malignant by the gold standard of pathology, evaluated by the pathological diagnosis. |
| 6 months |
| Complete ablation rate (at the lesion level) | The proportion of completely ablated lesions after ablation treatment among all the lesions undergoing ablation treatment, evaluated at 3 months, 1 year, 2 years, 3 years, and 5 years, respectively. | 3 months, 1 year, 2 years, 3 years, and 5 years |
| Local progression-free period (at the lesion level) | The time from when the patient receives treatment until the target lesion shows local progression. | 3 months, 1 year, 2 years, 3 years, and 5 years |
| Progression-free survival | The time from the patient receiving treatment until tumor progression or death from any cause (whichever occurs first). | 3 months, 1 year, 2 years, 3 years, and 5 years |
| Overall survival | The time from the patient receiving treatment until death from any cause. | 3 months, 1 year, 2 years, 3 years, and 5 years |
| Pulmonary function indicators (at the patient level) | The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline. | 1 year |
| The incidence of procedure-related complications (at the patient level) | The incidence of device- or ablation-related adverse events during the operation and within 1 month after the operation, graded according to the CTCAE v6.0 criteria, with bleeding additionally evaluated using the Nashville Delphi (2020) scale. | 1 month |
| ID | Term |
|---|---|
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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