Diagnosis and Treatment of Lung Lesions

Jisong Zhang25 enrolled

Overview

To evaluate the safety and feasibility of a single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Pulmonary Nodules Ablation Techniques

Interventions

A single-session "diagnose and treat" (one-stop) paradigm utilizing robotic-assisted bronchoscopy (RAB)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Navigation success rate

Time frame: Perioperatively

Ablation success rate

Time frame: Perioperatively

Post-operative complication rate

Time frame: Immediately after the procedure through hospital discharge

Secondary Outcomes

Diagnostic yield

Time frame: Perioperatively

Postoperative hospital stay

Time frame: Immediately after the procedure through hospital discharge

Local progression-free survival rate

Time frame: Three months after the operation

Data from ClinicalTrials.gov

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