Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules

NCT05383105 | Recruiting

• 1 other identifier: 202100352
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs. The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached. Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure. Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Conditions

Pulmonary Nodules, Solitary

Outcome Measures

Primary Outcomes (1)

• Successful diagnostic procedure

  Number of procedures with success to access the solitary pulmonary nodule

  During procedure

Interventions

Virtual bronchoscopic navigation PROCEDURE

Virtual bronchoscopy navigation (VBN) calculates the access to a solitary pulmonary nodule via a trans-parenchymal route. In contrast to the gold Standard transthoracic approach, with this technique also very small lesions (7 mm diameter), and lesions which cannot be reached via the transthoracic route - located in the inner two thirds of the lung - can be approached.

Also known as: Archimedes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing a Virtual bronchoscopy navigation procedure to assess a solitary pulmonary nodule.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk-Jan Slebos, MD PhD

  UMCG Groningen, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk-Jan Slebos, MD PhD

CONTACT

+31503612357; d.j.slebos@umcg.nl

Birgitta Hiddinga, MD

CONTACT

+31503612357; b.i.hiddinga@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: February 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

NL (1)