RecruitingNCT05383105

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


Sponsor

University Medical Center Groningen

Enrollment

100 participants

Start Date

Feb 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Interventions

PROCEDUREVirtual bronchoscopic navigation

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.


Locations(1)

UMCG Groningen

Groningen, Netherlands

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NCT05383105


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