ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

ulcerative colitis

Condition category

Condition code

Oral and Gastrointestinal

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]

Early detection / Screening

Intervention code [2]

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]

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]

1 year from enrollment

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2017

Actual

Date of last participant enrolment

Anticipated

1/12/2017

Actual

Date of last data collection

Anticipated

2/12/2018

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2139 - Concord

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Concord Hospital

Address [1]

Level 1 West
Hospital Road
Concord, NSW
2137

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

sydney local health district- concord zone

Ethics committee address [1]

Concord hospital
Hospital Road
Concord
NSW 2137

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2017

Approval date [1]

Ethics approval number [1]

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

Prof Rupert Leong

Address

Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137

Country

Australia

Phone

+61 2 97676111

Fax

rupert.leong@sswahs.nsw.gov.au

Contact person for public queries

Name

Aravind Gokul Tamilarasan

Address

Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137

Country

Australia

Phone

+61 2 97676111

Fax

gt_tamilarasan@hotmail.com

Contact person for scientific queries

Name

Aravind Gokul Tamilarasan

Address

Concord Hospital
Level 1 West
Hospital Road
Concord NSW 2137

Country

Australia

Phone

+61 2 97676111

Fax

gt_tamilarasan@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically