Safety and efficacy of a flexible endobronchial sampling instrument that obtains a CORe sample from KeY suspected areas of pulmonary and mediastinal lesions.

Recruiting

• Conditions: lung cancer; suspicious peripheral pulmonary lesions; 10029107

• Registration Number: NL-OMON56672
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

All patients with an indication for cone-beam CT guided navigation bronchoscopy
for the diagnosis of a peripheral pulmonary nodule are eligible for study
inclusion.

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

- ASA physical status 1-3
- Age above 18 years
- A single pulmonary nodule with an indication for diagnostic evaluation
following current clinical guidelines
- Subject is willing and able to give written informed consent for clinical
investigation participation prior to the procedure

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

- Contra-indication for navigation bronchoscopy
- Not fit to undergo navigation bronchoscopy
- Patient is pregnant
- Inability to consent
- Less than 18 years old
- Contra-indication for temporary interruption of the use of anticoagulant
therapy (acenocoumarin, warfarin, therapeutic dose of low molecular weight
heparins, clopidogrel or analogs, NOAC*s)
- Uncontrolled pulmonary hypertension
- Recent and/or uncontrolled cardiac disease
- Compromised upper airway (e.g., central airway stenosis for any reason such
that endobronchial access is considered unsafe)
- Patient is involved in another pulmonary intervention study
- Indication for minimal invasive biopsy of multiple nodules in one procedure
- Endobronchial visible tumor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this safety and efficacy study is to assess the<br /><br>overall diagnostic yield. Diagnostic yield is defined as the number of times<br /><br>the procedure was diagnostic (either malignant or benign), relative to the<br /><br>total number of attempted navigation procedures. The criteria for what<br /><br>constitutes a diagnostic sample will be modelled after the strict definitions<br /><br>as proposed by Vachani et al. (Vachani et al. Chest, 2020). When applying this<br /><br>definition, a diagnosis can only be determined based on pathology results from<br /><br>the study procedure and without follow-up information. Diagnostic outcomes are<br /><br>malignant or specific benign diagnoses (e.g., granulomatous inflammation,<br /><br>fungal infection). All other findings are categorized as non-diagnostic. This<br /><br>definition allows for a conservative analysis of the outcomes, and has strong<br /><br>clinical applicability.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of this study is to assess safety. The most common<br /><br>complication that can be expected are pneumothorax (with or without requiring<br /><br>chest tube drainage) and bleeding.<br /><br>Bleeding will be classified according to standardized definitions proposed by<br /><br>folch et al. (Folch et al. Chest, 2020)<br /><br>Other secundary outcomes are<br /><br>- Position confirmation of the instrument confirmed by cone-beam CT (CBCT)<br /><br>- Biopsy instrument characteristics, primarily: biopsy duration per sampling<br /><br>strategy and the number of biopsies taken<br /><br>- Ease of use of the research tool<br /><br>- The pathology outcome of tissue samples analyzed during rapid onsite<br /><br>evaluation (ROSE)<br /><br>- Suitability of the obtained tissue for any subsequent full molecular<br /><br>analysis.</p><br>