RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
ConditionPeripheral Pulmonary Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
Eligibility criteria
Qualifiers
Age ≥ 18 years, regardless of gender;
Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.
Disqualifiers
Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
Patients with pure ground-glass nodules suspected of malignancy on chest CT;
Female patients who are breastfeeding, pregnant, or planning pregnancy;
Patients with electromagnetic active implantable medical devices;
Trial design
Treatments tested in this trial
- Robotic bronchoscopy system
- Ultrathin bronchoscope combined with virtual bronchoscopic navigation
Treatment groups
186 Participants
are divided into 2 treatment groupsLocations
5Shandong Public Health Clinical Center250000, JinanShandong, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine200025, ShanghaiShanghai Municipality, China
Shanghai Chest Hospital200030, ShanghaiShanghai Municipality, China
Zhongshan Hospital，Fudan University200032, ShanghaiShanghai Municipality, China
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
Source ClinicalTrials.gov