A multicenter study evaluating the diagnostic value for vascular abnormalities of High Definition Bronchoscopy when combined with i-scan Imaging Technology compared to High Defintion Bronchoscopy alone
Recruiting
- Conditions
- lungcancer100386661002910710038737
- Registration Number
- NL-OMON40848
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
-Patients with indication for diagnostic bronchoscopy for suspected or proven lung cancer.
-ASA physical status 1-3.
-Age 18 years or older.
Exclusion Criteria
-Bleeding disorders.
-Indication for use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel).
-Known allergy for lidocaine.
-Known pulmonary hypertension.
-Recent and/or uncontrolled cardiac disease.
-Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason).
-ASA classification greater than or equal to 4.
-Pregnancy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determing the positive predictive value and diagnostic yield of HD+ i-scan<br /><br>bronchoscopy for vascular pattern detection compared to histology. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• To investigate the correlation of vascular abnormalities with histology<br /><br>• To investigate the impact of i-scan technology on the clinical approach or<br /><br>follow-up plan<br /><br>• To investigate the interobserver variability<br /><br>• Investigate diagnostic performance and determing the positive predictive<br /><br>value of HD+ i-scan bronchoscopy in comparison to normal HD-WL on demarcation<br /><br>of tumour margins</p><br>