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Trial registered on ANZCTR


Registration number
ACTRN12617000516381p
Ethics application status
Not yet submitted
Date submitted
8/03/2017
Date registered
10/04/2017
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing mucosal inflammation in ulcerative colitis patients using the new Optical Enhancement Magnification Colonoscope
Scientific title
Assessing mucosal inflammation in ulcerative colitis patients using the new Optical Enhancement Magnification Colonoscope
Secondary ID [1] 291401 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis 302420 0
Condition category
Condition code
Oral and Gastrointestinal 301987 301987 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 297436 0
Early detection / Screening
Intervention code [2] 297463 0
Diagnosis / Prognosis
Comparator / control treatment
no control group, however patients will have their colonoscopy images (with both optical enhancement and with white light illumination) compared with histology on biopsies.

Biopsies will be taken of the area of mucosa that was scored for endoscopic inflammation by Mayo score and by the optical enhancement modality.
Control group
Active

Outcomes
Primary outcome [1] 301407 0
Comparison of optical enhancement magnifying colonoscopy, Mayo endoscopic subscore using white light colonoscopy and Robarts histology index at assessing rectal mucosal inflammation.

Scores of mucosal inflammation will be assessed using the validated Mayo endoscopic subscore using white light colonoscopy and by the Robarts Histology index- both of which are methods of assessing inflammation severity currently in use. The new method being assessed will be optical enhancement magnification colonoscopy. Scoring of mucosal inflammation using this modality will be done by scoring the mucosal and vascular patterns and overall degree of inflammation.
Timepoint [1] 301407 0
1 year from enrollment
Secondary outcome [1] 332556 0
Whether severity of mucosal inflammation determined by optical enhancement magnifying colonoscopy and Robarts histology index predict risk of relapse.

Following on from comparison as to the accuracy with which optical enhancement magnification colonoscopy compares with white light colonoscopy and histological analysis; longitudinal follow up of the recruited patients will allow for long term assessment and stratification by original severity scores. This allows the development of a model to determine what level of severity (with regards to optical enhancement magnification colonoscopy) predicts or is more likely to develop disease relapse.

Relapse will be assessed by Mayo scores (both full score and endoscopic subscores) which is a validated tool for assessment of ulcerative colitis disease severity. This will be assessed by phone and in person follow up of patients. If patients need colonoscopy, they will have both white light and optical enhancement assessment.
Timepoint [1] 332556 0
1 year from enrollment

Eligibility
Key inclusion criteria
18 to 90 years old.
Confirmed diagnosis of ulcerative colitis
Clinically inactive disease
Inactive mucosal appearance on initial colonoscopy
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Colonic bleeding, erosions or ulceration on initial colonoscopy.
- Use of immunosuppressants for ulcerative colitis.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
no allocation concealment as all patients will undergo same process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7645 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 15553 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 295875 0
Hospital
Name [1] 295875 0
Concord Hospital
Address [1] 295875 0
Level 1 West
Hospital Road
Concord, NSW
2137
Country [1] 295875 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Concord Hospital, Department of Gastroenterology
Level 1 West
Hospital Road
Concord NSW
2137
Country
Australia
Secondary sponsor category [1] 294735 0
None
Name [1] 294735 0
Address [1] 294735 0
Country [1] 294735 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297154 0
sydney local health district- concord zone
Ethics committee address [1] 297154 0
Concord hospital
Hospital Road
Concord
NSW 2137
Ethics committee country [1] 297154 0
Australia
Date submitted for ethics approval [1] 297154 0
15/03/2017
Approval date [1] 297154 0
Ethics approval number [1] 297154 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73158 0
Prof Rupert Leong
Address 73158 0
Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137
Country 73158 0
Australia
Phone 73158 0
+61 2 97676111
Fax 73158 0
Email 73158 0
rupert.leong@sswahs.nsw.gov.au
Contact person for public queries
Name 73159 0
Dr Aravind Gokul Tamilarasan
Address 73159 0
Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137
Country 73159 0
Australia
Phone 73159 0
+61 2 97676111
Fax 73159 0
Email 73159 0
gt_tamilarasan@hotmail.com
Contact person for scientific queries
Name 73160 0
Dr Aravind Gokul Tamilarasan
Address 73160 0
Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137
Country 73160 0
Australia
Phone 73160 0
+61 2 97676111
Fax 73160 0
Email 73160 0
gt_tamilarasan@hotmail.com

No data has been provided for results reporting
Summary results
Not applicable