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
- PolypsBarrett Esophagus
- Interventions
- Device: Olympus SpectrumDevice: Olympus Elite
- Registration Number
- NCT03073226
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Patients attending for Barrett's surveillance OR
- Patients attending for colonic polyp surveillance or screening
- Patients are willing and able to give informed consent.
- Polyp syndromes (eg FAP or Lynch Syndrome)
- Known history of IBD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Barrett's surveillance Olympus Spectrum Olympus Spectrum Barrett's surveillance with Olympus Spectrum. Barrett's Surveillance Olympus Elite Olympus Elite Barrett's surveillance with Olympus ELITE. Polyp Surveillance Olympus Spectrum Olympus Spectrum Colonic polyp surveillance/screening with Olympus Spectrum. Polyp Surveillancewith Olympus ELITE. Olympus Elite Colonic polyp surveillance/screening with Olympus ELITE.
- Primary Outcome Measures
Name Time Method Sensitivity Baseline and 1 day Difference in the sensitivity of in vivo lesion characterisation between Lucera Elite vs Lucera Spectrum as compared to final histology.
- Secondary Outcome Measures
Name Time Method Endoscopists confidence Baseline and 1 day Difference in endoscopists' confidence scores in lesion characterisation between new and current technologies.
Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology. Baseline and 1 day Difference in clarity of images/videos between Lucera Elite and Lucera Spectrum technology.
Sensitivity of Dual Focus technology Baseline and 1 day Difference in sensitivity of lesion characterisation when using dual focus technology.
Trial Locations
- Locations (1)
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom