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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Barrett Esophagus, Polyps

Intervention / Treatment
-----------------
* Device: Olympus Elite
* Device: Olympus Spectrum


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |