Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS

Not Applicable

Completed

• Conditions: Bronchial Neoplasms
• Interventions: Device: navigated bronchoscopy

• Registration Number: NCT02493023
• Lead Sponsor: St. Olavs Hospital

Brief Summary

Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.Electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. In this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

Detailed Description

This is an accuracy study of a new automatic CT-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (EBUS). An in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3D) maps made from the patients' own preoperative CT images. The navigation system is used for acquiring position data from a bronchoscope or EBUS-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. When targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative CT images to navigate directly, precisely and accurately to the area of interest. Functional systems for navigated bronchoscopy and EBUS may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-06
• Study First Posted: 2015-07-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
• informed consent

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
navigated bronchoscopy	navigated bronchoscopy	-

Primary Outcome Measures

Name	Time	Method
endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT images	48 hours	intraoperative positional data of bronchoscope or endobronchial ultrasound scope (EBUS) measured and stored in navigation system software, used for registration and navigation system accuracy calculations

Secondary Outcome Measures

Name	Time	Method
patient reported satisfaction	48 hours	enquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
duration of procedure	48 hours	time from first entry of endoscope through vocal cords to final withdrawal of endoscope
adverse events	48 hours	procedure related adverse events or unexpected incidents registrated

Trial Locations

Locations (1)

Department of Thoracic Medicine, St Olavs Hospital; 🇳🇴 Trondheim, Norway