Using virtual bronchoscopic navigation to improve diagnosis of lung nodules
Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules
This study tests if a new method using virtual bronchoscopic navigation can help doctors diagnose lung nodules more safely and effectively than traditional procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05383105 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of virtual bronchoscopic navigation (VBN) in diagnosing solitary pulmonary nodules (SPN) that may be cancerous. The study aims to compare the diagnostic yield of VBN with traditional transthoracic CT-guided procedures, which carry a higher risk of complications. By utilizing a transparenchymal approach, the study seeks to safely access small or difficult-to-reach nodules located in the inner two-thirds of the lung. Participants will be monitored for the success of the procedure and any associated complications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with suspicious pulmonary nodules larger than 6 mm that are accessible via bronchoscopy.
Not a fit: Patients with contraindications for bronchoscopy or general anesthesia, or those with severe pulmonary conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more accurate diagnoses of lung nodules, potentially improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with similar endobronchial techniques, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 * pulmonary nodule(s) suspicious for malignancy or metastases of a known primary tumour * a distinct nodule with a diameter of \>6 mm in its largest dimension * nodule located in the parenchymal tissue \>1 cm from the pleura and bronchoscopically accessible through a point of entry * willing to give informed consent to the procedure. Exclusion Criteria: * any contraindication to undergo bronchoscopy * contraindication for general anaesthesia * inability to stop anticoagulants or antiplatelets agents according to the UMCG protocol * childbearing or breastfeeding women * moderate to seyere pulmonary fibrosis * severe emphysema with bullae \> 5 cm m the vicinity of the target nodule or tunnel.
Where this trial is running
Groningen
- UMCG Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dirk-Jan Slebos, MD PhD — UMCG Groningen, The Netherlands
- Study coordinator: Dirk-Jan Slebos, MD PhD
- Email: d.j.slebos@umcg.nl
- Phone: +31503612357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.