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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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.
Shanghai Chest Hospital
Shanghai, China
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.
Time frame: 6 months
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.
Time frame: 6 months
Sensitivity of malignancy (at the lesion level)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month