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

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 - i-scan multicenter study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40848

Enrollment

Registered

2014-10-02

Start date

2014-10-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lungcancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Determing the positive predictive value and diagnostic yield of HD+ i-scan bronchoscopy for vascular pattern detection compared to histology.	—

Secondary

Measure	Time frame
• To investigate the correlation of vascular abnormalities with histology • To investigate the impact of i-scan technology on the clinical approach or follow-up plan • To investigate the interobserver variability • Investigate diagnostic performance and determing the positive predictive value of HD+ i-scan bronchoscopy in comparison to normal HD-WL on demarcation of tumour margins	—

Countries

Netherlands

Outcome results