Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus
- Conditions
- Endoscopy
- Interventions
- Device: Hyper-Spectral Endoscopy
- Registration Number
- NCT06119906
- Lead Sponsor
- University of Cambridge
- Brief Summary
The goal of this clinical trial is to assess the efficacy of hyperspectral endoscopic imaging to distinguish neoplasia from non-dysplastic Barrett's oesophagus in vivo. The main outcome measures are: 1) Classification of spectral patterns corresponding to neoplastic vs non-neoplastic Barrett's; 2) Image quality assessed by the endoscopist by VAS rating the level of confidence in delineating the area of interest; 3) Time to perform hyperspectral imaging; 4) Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns.
Participants will firstly undergo a standard endoscopy, followed by another endoscopy using the experimental HySe device. Subsequently, patients will receive biopsies according to Seattle protocol, and up to 6 additional (optional) snap frozen research biopsies.
- Detailed Description
This trial is designed to evaluate the feasibility of hyperspectral endoscopic imaging in vivo.
The team has developed a custom hyperspectral endoscope based around a commercially available, standard-of-care endoscopy stack from Olympus (Tokyo, Japan). In this system, the original gastroscope, video processor and display are used with a modified light source that incorporates a laser with tunable wavelength for illuminating the scene through the endoscope. A live video feed from the gastroscope is displayed on the endoscopy theatre monitors and can be acquired and saved in the native video acquisition system.
Given that it is essential in the pilot study to assess the detection of neoplastic lesions in a small patient cohort, we will artificially enrich for patients with early neoplasia by including patients with previously recognized early neoplasia within Barrett's oesophagus (high grade dysplasia and intramucosal adenocarcinoma). These patients will receive a clinically indicated endoscopy to be assessed to determine eligibility for endoscopic treatment, and imaging would be done at this time point. This will allow the team to have sufficient number of outcomes to have preliminary data on diagnostic accuracy and be able to power future studies in non-enriched patient cohorts.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Male or female subjects over 18 years.
- Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm if circumferential (C≥2 according to Prague classification) or 3 cm if not circumferential (maximal extent M≥3, according to Prague classification).
- Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy.
- History of oesophageal stricture precluding passage of the endoscope.
- Pregnancy, or planned pregnancy during the course of the study.
- Currently breastfeeding.
- Any history of oesophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices on initial treatment endoscopy.
- Any history of oesophageal surgery, except for uncomplicated fundoplication.
- History of coagulopathy, with INR>1.3 and/or platelet count of <75,000.
- On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard + Experimental Endoscopy Hyper-Spectral Endoscopy The endoscopist will intubate the patient with a high resolution white light endoscope (Olympus GIFH290Z or GIF-EZ1500) and thoroughly inspect the mucosal surface of the oesophagus. A careful note will be made of any visible lesion with their location, and the surrounding mucosa will be marked with cautery to localize the lesion for further hyperspectral imaging and biopsy. We will aim to identify at least two areas of interest per patient with the possibility to select more if the length of the Barrett's oesophagus allows. The endoscopist will remove the standard of care endoscope and then reintubate the patient with the experimental device and perform unbiased imaging first followed by targeted imaging of the endoscopic areas previously marked
- Primary Outcome Measures
Name Time Method Contrast of neoplastic vs non-neoplastic Barrett's Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure Pixel intensity value at 16 different wave lengths in endoscopic areas of interest as compared with standard-of-care RGB white light endoscopy
- Secondary Outcome Measures
Name Time Method Time to perform hyperspectral imaging During the intervention Time in Minutes
Image quality of Hyper-Spectral Endoscopy in vivo Immediately after the intervention Visual analogue scale (VAS) rating the level of confidence in delineating the area of interest
Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure Intensity of staining of Immunohistochemical markers
Image quality of Hyper-Spectral Endoscopy after post-hoc analysis Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure Visual analogue scale (VAS) rating the level of confidence in delineating the area of interest
Trial Locations
- Locations (1)
Cambridge University Hospital
🇬🇧Cambridge, County (optional), United Kingdom