HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study

NCT ID: NCT02285426

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-20
• Study Completion Date: 2017-06-05

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.

Conditions

Lungcancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

suspected lungcancer

Patients will undergo a bronchoscopy with the Pentax EB1990i HD-bronchoscope investigating the entire bronchial tree. The HD+ bronchoscopy needs to be performed in a standardized way using 3 different imaging modes:

1. HD+bronchoscopy

2. HD+bronchoscopy + i-Scan 1

3. HD+bronchoscopy + i-Scan 2

Pentax EB-1990i HD-bronchoscope guided biopsy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik HF van der Heijden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Ospedale Umberto I, Via Dante Alighieri n.1

Ravenna, RA, Italy

RadboudUMC

Nijmegen, Gelderland, Netherlands

St-Petersburg Research Institute of TB and Thoracic Surgery

Saint Petersburg, , Russia

Hospital Universitario Santa Lucia

Murcia, , Spain

Countries

Italy; Netherlands; Russia; Spain

References

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.

Reference Type: DERIVED

PMID: 29862031 (View on PubMed)

Other Identifiers

NL5012109114

Identifier Type: -

Identifier Source: org_study_id