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

Portsmouth Hospitals NHS Trust

Status: Completed

Conditions: Polyps; Barrett Esophagus

Treatments: Device: Olympus Spectrum; Device: Olympus Elite

Study type: Interventional

Funder types: Other

Identifiers

NCT03073226

PHT/2015/105

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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232 participants in 4 patient groups

Barrett's surveillance Olympus Spectrum

Experimental group

Description:

Barrett's surveillance with Olympus Spectrum.

Treatment:

Device: Olympus Spectrum

Barrett's Surveillance Olympus Elite

Experimental group

Description:

Barrett's surveillance with Olympus ELITE.

Treatment:

Device: Olympus Elite

Polyp Surveillance Olympus Spectrum

Experimental group

Description:

Colonic polyp surveillance/screening with Olympus Spectrum.

Treatment:

Device: Olympus Spectrum

Polyp Surveillancewith Olympus ELITE.

Experimental group

Description:

Colonic polyp surveillance/screening with Olympus ELITE.

Treatment:

Device: Olympus Elite