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

NCT03073226 | Completed DMC

• 1 other identifier: PHT/2015/105
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett Esophagus; Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.

  Baseline and 1 day

• Sensitivity of Dual Focus technology

  Baseline and 1 day

• Endoscopists confidence

  Baseline and 1 day

Study Arms (4)

Barrett's surveillance Olympus Spectrum

EXPERIMENTAL

Barrett's surveillance with Olympus Spectrum.

Device: Olympus Spectrum

Barrett's Surveillance Olympus Elite

EXPERIMENTAL

Barrett's surveillance with Olympus ELITE.

Device: Olympus Elite

Polyp Surveillance Olympus Spectrum

EXPERIMENTAL

Colonic polyp surveillance/screening with Olympus Spectrum.

Device: Olympus Spectrum

Polyp Surveillancewith Olympus ELITE.

EXPERIMENTAL

Colonic polyp surveillance/screening with Olympus ELITE.

Device: Olympus Elite

Interventions

Olympus Elite DEVICE

New generation Olympus endoscope

Barrett's Surveillance Olympus Elite; Polyp Surveillancewith Olympus ELITE.

Olympus Spectrum DEVICE

Current generation Olympus endoscope

Barrett's surveillance Olympus Spectrum; Polyp Surveillance Olympus Spectrum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Barrett Esophagus; Polyps

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: February 6, 2016
• Primary Completion: November 1, 2017
• Study Completion: February 6, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)