A Prospective Study Comparing the Accuracy of Olympus Lucera Spectrum Technology vs Olympus Lucera Elite Technology in the in Vivo Diagnosis of Barrett's Oesophagus and Colorectal Polyps: The ELITE Study (ELITE)

Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes.

Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years.

Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal.

Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company.

Study Overview

• Status: Completed
• Conditions: Polyps; Barrett Esophagus
• Intervention / Treatment: Device: Olympus Spectrum; Device: Olympus Elite

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients attending for Barrett's surveillance OR
• Patients attending for colonic polyp surveillance or screening
• Patients are willing and able to give informed consent.

Exclusion Criteria:

• Polyp syndromes (eg FAP or Lynch Syndrome)
• Known history of IBD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barrett's surveillance Olympus Spectrum; Barrett's surveillance with Olympus Spectrum.	Device: Olympus Spectrum; Current generation Olympus endoscope
Experimental: Barrett's Surveillance Olympus Elite; Barrett's surveillance with Olympus ELITE.	Device: Olympus Elite; New generation Olympus endoscope
Experimental: Polyp Surveillance Olympus Spectrum; Colonic polyp surveillance/screening with Olympus Spectrum.	Device: Olympus Spectrum; Current generation Olympus endoscope
Experimental: Polyp Surveillancewith Olympus ELITE.; Colonic polyp surveillance/screening with Olympus ELITE.	Device: Olympus Elite; New generation Olympus endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.	Baseline and 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.	Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.	Baseline and 1 day
Sensitivity of Dual Focus technology	Difference in sensitivity of lesion characterisation when using dual focus technology.	Baseline and 1 day
Endoscopists confidence	Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.	Baseline and 1 day

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Precancerous Conditions; Polyps; Barrett Esophagus
• Other Study ID Numbers: PHT/2015/105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No