Clinical trial NCT02285426: HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lungcancer
Keywords: i-scan
histology
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected or proven lung cancer are eligible if there is an indication for bronchoscopy. Eligible are patients with ASA physical status 1-3 and aged 18 years or older.

Brief summary: Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways and pivotal for the diagnosis and staging of lung cancer. Further technological improvements have resulted in high definition (HD+) images and advanced image enhancement technique (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination with i-scan technology is superior to HD+WL (white light) for detecting endobronchial vascular changes. In this study we aim to correlate these vascular changes to histology and hypothesize that these vascular changes are related to (pre-) malignant changes and that the addition of i-scan is superior to HD+ WL.

Detailed description: Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will be performed by an experienced chest physician under local anaesthesia use and type of sedation following local protocol. Bronchoscopy will be performed in a standardized order using three different imaging modes. The order of the different modes will be randomized to avoid induced scope and / or cough lesion bias. High definition digital videos will be made from all procedures without in screen patient identification, but using a study code. The three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and HD+ surface enhancement and tone enhancement (TE-c, i-scan2).

When sites with abnormal or suspicious vascular patterns are detected the investigator grade these findings using a visual classification scale \[adapted from Herth JTO 2009 \& Zaric Med Oncol 2013\] and change to a regular bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control. Finally any other indicated procedures will be performed at the discretion of the local investigator.

Eligibility 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.
* Signed and dated patient informed consent.

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.
* Inability to consent.

Primary outcomes:
measure: positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions
timeFrame: 7 days
Secondary outcomes:
measure: correlation between endobronchial vascular patterns and histology
timeFrame: 7 days
measure: interobserver variability for detecting vascular abnormalities
timeFrame: 3 - 12 months
measure: impact of HD-bronchoscopy on clinical decision
timeFrame: 1-56 days
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Ospedale Umberto I, Via Dante Alighieri n.1
state: RA
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
city: Saint-Petersburg
country: Russian Federation
facility: St-Petersburg Research Institute of TB and Thoracic Surgery
city: Murcia
country: Spain
facility: Hospital Universitario Santa Lucia
Study officials:
affiliation: Principal Investigator
name: Erik HF van der Heijden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Heijden EHFM, Candoli P, Vasilev I, Messi A, Perez Pallares J, Yablonskii P, van der Vorm A, Schuurbiers OCJ, Hoefsloot W. Image enhancement technology in bronchoscopy: a prospective multicentre study in lung cancer. BMJ Open Respir Res. 2018 May 18;5(1):e000295. doi: 10.1136/bmjresp-2018-000295. eCollection 2018.