Inflammatory Bowel DiseaseNCT02098798
Comparison of Surveillance Colonoscopy Techniques in Patients With IBD
An observational study of Inflammatory Bowel Disease, run by University of Calgary at 1 site in Canada.
Trial summary
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- HD Colonoscopy, HD Colonoscopy + iSCAN and HD Colonoscopy + dye spray
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inflammatory bowel disease patients undergoing surveillance colonoscopy
Who may be able to join
- Clinical and histological diagnosis of UC or colonic CD-extensive or pancolitis.
- UC -CD Disease duration 8 years from diagnosis UC-CD with associated primary sclerosing cholangitis from diagnosis Ulcerative Colitis Activity Index Mayo score 0-1 (inactive disease) Crohn's disease Activity Index - Harvey Bradshaw score <4 (dysplasia detection requires quiescent inflammatory bowel disease)
Who cannot join
- Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary, Foothills Medical Centre
Calgary, Alberta, T2N 4N1
About this study
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or UC.
We hypothesized that these novel endoscopic techniques using High definition colonoscopy with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in patients with long standing IBD.
Read more
We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense and considerable time.
In addition, we can hope to produce evidence and inform the way in which we perform surveillance colonoscopy especially without large number of multiple random biopsies but only few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN technique as is already the European practice in several centres.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- HD Colonoscopy, HD Colonoscopy + iSCAN, HD Colonoscopy + dye spray
- Keywords
- Dysplasia, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD ColonoscopyProcedure or surgery
High definition colonoscopy procedure in surveillance colonoscopy
HD Colonoscopy + iSCANProcedure or surgery
HD Colonoscopy + dye sprayProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HD | High Definition Colonoscopy alone Receives: Procedure: HD Colonoscopy | |
| HD + iSCAN | HD colonoscopy + iSCAN Receives: Procedure: HD Colonoscopy + iSCAN | |
| HD + Dye | High definition colonoscopy + dye spraying chromoendoscopy Receives: Procedure: HD Colonoscopy + dye spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iacucci Marietta MD,PhD, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098798
- Sponsor's protocol ID
- REB13-0960
- Status last verified
- Aug 2016
- First submitted
- 25 Mar 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surveillance Colonoscopy Techniques in Patients With IBD
- ClinicalTrials.gov ID
- NCT02098798
- Acronym / sponsor ID
- REB13-0960
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Dysplasia, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or UC.
We hypothesized that these novel endoscopic techniques using High definition colonoscopy with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in patients with long standing IBD.
We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense and considerable time.
In addition, we can hope to produce evidence and inform the way in which we perform surveillance colonoscopy especially without large number of multiple random biopsies but only few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN technique as is already the European practice in several centres.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HD | – | Procedure: HD ColonoscopyHigh Definition Colonoscopy alone |
| HD + iSCAN | – | Procedure: HD Colonoscopy + iSCANHD colonoscopy + iSCAN |
| HD + Dye | – | Procedure: HD Colonoscopy + dye sprayHigh definition colonoscopy + dye spraying chromoendoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory bowel disease patients undergoing surveillance colonoscopy
Key inclusion criteria (2 listed)
- Clinical and histological diagnosis of UC or colonic CD-extensive or pancolitis.
- UC -CD Disease duration 8 years from diagnosis UC-CD with associated primary sclerosing cholangitis from diagnosis Ulcerative Colitis Activity Index Mayo score 0-1 (inactive disease) Crohn's disease Activity Index - Harvey Bradshaw score <4 (dysplasia detection requires quiescent inflammatory bowel disease)
Key exclusion criteria (1 listed)
- Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD ColonoscopyHigh definition colonoscopy procedure in surveillance colonoscopy | Procedure or surgery | HD |
| HD Colonoscopy + iSCAN | Procedure or surgery | HD + iSCAN |
| HD Colonoscopy + dye spray | Procedure or surgery | HD + Dye |
Primary outcome
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
Time frame: At the time of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy (time frame: At the time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.