None listed
Conditions
Brief summary
Optical enhancement with magnification is a new modality of colonoscopy offered by Pentax Medical (Pentax EPK i-series). It uses optical filters that limit light of certain wavelengths to increase resolution and image contrast of mucosa and underlying blood vessels seen at endoscopy, similar to narrow band imaging technology. The concept is to use pre-image processing by means of filters whilst retaining post-image processing to digitally enhance the image. This dual enhancement (optical and digital) allows for better clarity of the endoscopic image. The technology has also improved on the major barrier encountered in previous iterations of optical filters (reduced illumination), by connecting the peaks of the haemoglobin absorption spectrum (415, 540 and 570mm) allowing a continuous wavelength spectrum. This achieves a higher overall transmittance of the optical filter and an increased level of illumination. Using the optical filter increases the ability to assess microvascular patterns and surface structures, which is vital in assessing mucosal healing in ulcerative colitis patients Study type Prospective, interventional study investigating the ability of a new optical enhancement endoscopic technology to accurately assess mucosal inflammation and develop predictors of disease relapse. Study population and recruitment This study will prospectively recruit patients, aged 18 years and older, with ulcerative colitis to investigate their risk of relapse using a new optical enhancement technology from Pentax Medical. This will be done by scoring a patient’s degree of rectal mucosal inflammation using this optical enhancement technology and correlating it with the current gold standard- histopathologic examination of biopsy specimens. If the patient is to be included in the study, a thorough endoscopic examination of the rectum will be performed. This will be done using the optical enhancement feature of the Pentax endoscope. The rectal mucosa will be examined and the pit pattern of the rectal mucosa will be recorded. Details of the vascular pattern and surface structures will be recorded. The area with the most severe mucosal changes will be biopsied for histology. Biopsies will be examined by a pathologist who is blinded to the patient’s clinical history and endoscopic pit pattern grade. The biopsies will be analysed according to the Robarts index, which is a validated score for assessing the degree of mucosal inflammation in ulcerative colitis based on histologic features including architectural change, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction, and erosion or ulceration.
Interventions
Colonoscopy and comparison between optical enhancement technology and white light (both modalities will be assessed in the same patient) and histological analysis of biopsy specimens. These colonoscopies will be performed by trained endoscopists, ie: consultants or advanced trainees. They don't have any increased risk compared to routine colonoscopies that these patients would undergo regardless of involvement in the study.
Colonoscopies will occur in endoscopy unit of a tertiary hospital. Freq
Colonoscopy and comparison between optical enhancement technology and white light (both modalities will be assessed in the same patient) and histological analysis of biopsy specimens. These colonoscopies will be performed by trained endoscopists, ie: consultants or advanced trainees. They don't have any increased risk compared to routine colonoscopies that these patients would undergo regardless of involvement in the study. Colonoscopies will occur in endoscopy unit of a tertiary hospital. Frequency will depend on patient's clinical need for endoscopy but usually at 3-6 month intervals to assess for mucosal healing. 1) Optical enhancement with magnification is a new modality of colonoscopy offered by Pentax Medical (Pentax EPK i-series). It uses optical filters that limit light of certain wavelengths to increase resolution and image contrast of mucosa and underlying blood vessels seen at endoscopy, similar to narrow band imaging technology. The concept is to use pre-image processing by means of filters whilst retaining post-image processing to digitally enhance the image. This dual enhancement (optical and digital) allows for better clarity of the endoscopic image. The technology has also improved on the major barrier encountered in previous iterations of optical filters (reduced illumination), by connecting the peaks of the haemoglobin absorption spectrum (415, 540 and 570mm) allowing a continuous wavelength spectrum. This achieves a higher overall transmittance of the optical filter and an increased level of illumination. White light would be performed first and then followed by optical enhancement and this would take a total of about 20 minutes so that direct comparison could be made and photos will be taken with both modalities. This may occur more than once and could occur at each surveillance colonoscopy in order to assess mucosal healing with both modalities. This may be as frequent as every 3 months for 1 year (meaning 4 colonoscopies total, though often the procedure will be limited to assessment of the rectal mucosa meaning a shorter procedure).
Sponsors
Concord Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
18 to 90 years old. Confirmed diagnosis of ulcerative colitis Clinically inactive disease Inactive mucosal appearance on initial colonoscopy
Exclusion criteria
- Colonic bleeding, erosions or ulceration on initial colonoscopy. - Use of immunosuppressants for ulcerative colitis.
Outcome results
None listed