CLE-guided bronchoscopy for peripheral lung cancer diagnosis: a Randomized Controlled Trial
- Conditions
- 10038666Peripheral lung cancer
- Registration Number
- NL-OMON53986
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
• >=18 years of age
• Suspected malignant peripheral lung lesion with an indication for a
bronchoscopic diagnostic work-up
• Solid part of the lesion must be >10 mm
• Largest dimension of lesion size on CT equal to or less than 30 mm
• Bronchus sign on pre-procedural CT or estimated confidence for successful
navigation to the nodule resulting in a r-EBUS signal
• Ability to understand and willingness to sign a written informed consent
• Inability or non-willingness to provide informed consent
• Patients with an endobronchial visible lung tumor on bronchoscopic inspection
• Patients in which the target lesion is within reach of the linear EBUS scope
• Failure to comply with the study protocol
• Patients with known allergy for fluorescein or risk factors for an allergic
reaction
• Pregnant or breastfeeding women
• Patients with hemodynamic instability
• Patients with refractory hypoxemia
• Patients with a therapeutic anticoagulant that cannot be held for an
appropriate interval before the procedure
• Patients who are unable to tolerate general anesthesia according to the
anesthesiologist
• Patient undergoing chemotherapy as several chemotherapies have fluorescent
properties at the same wavelength (e.g. doxorubicin)
• Inability to follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine if the addition of nCLE-imaging to conventional bronchoscopic<br /><br>peripheral lung lesion analysis results in an improved diagnostic yield.</p><br>
- Secondary Outcome Measures
Name Time Method