Ablation Techniques, Peripheral Pulmonary Nodules
Conditions
Keywords
Peripheral pulmonary lesions, Tumor ablation, Robotic-assisted bronchoscopy, Single-session procedure
Brief summary
To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
Detailed description
The increasing detection of peripheral pulmonary lesions (PPLs) necessitates effective, lung-sparing therapies. For inoperable patients, current guidelines dictate a staged workflow involving diagnostic biopsy followed by a separately scheduled ablation. This study aims to evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).
Interventions
PROCEDUREA single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)
Inoperable patients underwent synchronous biopsy and ablation under RAB and cone-beam CT guidance. Following confirmation of atypical cells by rapid on-site evaluation (ROSE), individualized ablation (cryoablation, radiofrequency ablation, or synergistic irreversible electroporation) was performed in the same anesthetic setting.
Sponsors
Jisong Zhang
Sir Run Run Shaw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Have peripheral pulmonary lesions (PPLs). 3. Meet at least one of the following conditions: (1) Deemed medically inoperable due to surgical intolerance; (2) Have newly developed or residual nodules after previous lung cancer surgery; (3) Present with multiple bilateral pulmonary nodules; or (4) Explicitly refuse surgical resection.
Exclusion criteria
1. Centrally located tumors invading the main bronchi. 2. Uncorrectable coagulopathy. 3. Evidence of advanced nodal (N2/N3) or distant metastatic disease (unless the PPL represented an oligometastatic lesion targeted with curative intent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Navigation success rate | Perioperatively |
| Ablation success rate | Perioperatively |
| Post-operative complication rate | Immediately after the procedure through hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic yield | Perioperatively |
| Postoperative hospital stay | Immediately after the procedure through hospital discharge |
| Local progression-free survival rate | Three months after the operation |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJisong Zhang, MD
Sir Run Run Shaw Hospital
Outcome results
None listed