CT-controlled advanced navigation techniques for transbronchial pulmonary lesion access; evaluation of electromagnetic navigation based diagnostic yield.

Completed

Conditions: early stage lung cancer
peripheral pulmonary nodules
10029107

Registration Number: NL-OMON44337

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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 18 years or older.
* A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Bleeding disorders.
* Less than 18 years old.
* Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel or analogs, NOAC*s).
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent and/or uncontrolled cardiac disease.
* Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
* ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
* Pregnancy.
* Inability to consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The first objective is to exploratively study diagnostic yield and navigational<br /><br>accuracy of the studied combination of imaging and navigational modalities. For<br /><br>studying navigational accuracy we will evaluate if the combination of the<br /><br>studied modalities is able to navigate to the peripheral lung lesion in all<br /><br>cases. If not and/or an unrepresentative diagnosis is found, an exploratory<br /><br>analysis will be performed to correlate lesion characteristics to study<br /><br>procedure performance.</p><br>

Secondary Outcome Measures