RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

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 groups

Sponsors and collaborators