Pulmonary Nodules
Conditions
Brief summary
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.
Interventions
PROCEDURERobotic-assisted bronchoscopy-guided synchronous biopsy and radiofrequency ablation for pulmonary nodules
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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old; * Chest CT indicates pulmonary nodules, highly suspected of being malignant; * Size of pulmonary nodules: 8 mm \< maximum diameter ≤ 30 mm, and the number of pulmonary nodules requiring intervention ≤ 3; * Preoperative imaging evaluation indicates no clear lymph node metastasis or distant metastasis (cT1N0M0); * Multidisciplinary evaluation shows that the patient cannot tolerate surgery and radiotherapy, or the patient refuses surgery and radiotherapy after full informed consent; * The patient understands and agrees to receive synchronous biopsy and ablation treatment under robotic-assisted bronchoscopy and signs a written informed consent form.
Exclusion criteria
* Patients who cannot tolerate general anesthesia due to advanced age or severe cardiopulmonary diseases, or other reasons; * The target nodule has been diagnosed as a malignant tumor or metastasis; * Patients with severe bleeding tendency or uncorrectable coagulation disorder (platelet count \< 50×10\^9 /L, prothrombin time \> 18s, prothrombin activity \< 40%); * Severe pulmonary fibrosis and pulmonary hypertension; * Anticoagulant or anti-platelet drugs have not been discontinued for the required time before surgery; * Implanted cardiac pacemaker, defibrillator, or other electronic implants; * Presence of important blood vessels that cannot be avoided along the biopsy path; * Other conditions that the investigators consider not suitable for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate (at the lesion level) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy diagnostic yield (at the lesion level) | 6 months | 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. |
| Sensitivity of malignancy (at the lesion level) | 6 months | 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. |
| Complete ablation rate (at the lesion level) | 3 months, 1 year, 2 years, 3 years, and 5 years | 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. |
| Local progression-free period (at the lesion level) | 3 months, 1 year, 2 years, 3 years, and 5 years | The time from when the patient receives treatment until the target lesion shows local progression. |
| Progression-free survival | 3 months, 1 year, 2 years, 3 years, and 5 years | The time from the patient receiving treatment until tumor progression or death from any cause (whichever occurs first). |
| Overall survival | 3 months, 1 year, 2 years, 3 years, and 5 years | The time from the patient receiving treatment until death from any cause. |
| Pulmonary function indicators (at the patient level) | 1 year | The change level of indicators such as FEV₁ and DLCO 1 year after surgery compared with the preoperative baseline. |
| The incidence of procedure-related complications (at the patient level) | 1 month | 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. |
Countries
China
Contacts
CONTACTJiayuan Sun, MD, PhD
STUDY_DIRECTORJiayuan Sun, MD, PhD
Shanghai Chest Hospital
Outcome results
None listed