A Study on the Feasibility and Safety of Single-Session Robot-Assisted Bronchoscopy for Diagnosis and Ablation of Pulmonary Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Have peripheral pulmonary lesions (PPLs).
- •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
- •Centrally located tumors invading the main bronchi.
- •Uncorrectable coagulopathy.
- •Evidence of advanced nodal (N2/N3) or distant metastatic disease (unless the PPL represented an oligometastatic lesion targeted with curative intent).
Arms & Interventions
One-stop treatment group
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.
Intervention: A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB) (Procedure)
Investigators
Jisong Zhang
Doctor of Medicine
Sir Run Run Shaw Hospital