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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02285426
Other study ID # NL5012109114
Secondary ID
Status Completed
Phase
First received October 27, 2014
Last updated April 11, 2018
Start date October 20, 2014
Est. completion date June 5, 2017

Study information

Verified date April 2018
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date June 5, 2017
Est. primary completion date June 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pentax EB-1990i HD-bronchoscope guided biopsy
3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree. When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality [visual scale adapted from Herth 2009 and Zaric 2013] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.

Locations

Country Name City State
Italy Ospedale Umberto I, Via Dante Alighieri n.1 Ravenna RA
Netherlands RadboudUMC Nijmegen Gelderland
Russian Federation St-Petersburg Research Institute of TB and Thoracic Surgery Saint-Petersburg
Spain Hospital Universitario Santa Lucia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Countries where clinical trial is conducted

Italy,  Netherlands,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions Determing the positive predictive value of HD+ i-scan bronchoscopy for vascular pattern detection . 7 days
Secondary correlation between endobronchial vascular patterns and histology relate grading of detected vascular abnormalities with histology outcome of biopsies 7 days
Secondary interobserver variability for detecting vascular abnormalities compare bronchoscopist reported outcome to central review of obtained videos to determine interobserver variability 3 - 12 months
Secondary impact of HD-bronchoscopy on clinical decision interview based evaluation to investigate whether the use of of i-scan technology and or the outcome of study-detected vascular sites changed the clinical approach or follow-up plan 1-56 days
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