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Endoscopic Imaging Techniques for Ulcerative Colitis
N/A
Recruiting
Led By Raf Bisschops, MD PhD
Research Sponsored by Universitaire Ziekenhuizen Leuven
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Active ulcerative colitis, > 20 cm from the margo ani
Personal history of colorectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the endpoint can be assessed immediately after the endoscopy.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing new endoscopic imaging techniques to see if they're better than the current gold standard (chromo-endoscopy) for detection neoplastic lesions in patients with longstanding ulcerative colitis.
Who is the study for?
This trial is for adults over 18 with long-term ulcerative colitis (at least 8 years since diagnosis or pancolitis, and at least 10 years for left-sided colitis). They must have had a previous endoscopy over a year ago and be able to give informed consent. It's not for those currently with active ulcerative colitis, personal history of colorectal cancer, allergy to methylene blue, or pregnant women.
What is being tested?
The study compares traditional chromoendoscopy against newer techniques like NBI, FICE, and I-scan in detecting precancerous changes in patients with longstanding ulcerative colitis. The goal is to see if these new methods are as effective but more efficient than the current gold standard.
What are the potential side effects?
Potential side effects may include discomfort from the endoscopic procedure itself such as cramping or bloating. Allergic reactions could occur in those sensitive to dyes used in chromoendoscopy but this would exclude them from participation.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active ulcerative colitis affecting a large area.
Select...
I have had colorectal cancer in the past.
Select...
I am unable or unwilling to give informed consent.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy
Secondary study objectives
Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique.
The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy.
The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy
Other study objectives
The difference in total number of non-neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: PENTX i-scanExperimental Treatment1 Intervention
Group F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings
Group II: OLYMPUS NBIExperimental Treatment1 Intervention
Group B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)
Group III: FUJINON FICEExperimental Treatment1 Intervention
Group D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4
Group IV: OLYMPUS CHROMOActive Control1 Intervention
Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Group V: FUJINON CHROMOActive Control1 Intervention
Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Group VI: PENTAX CHROMOActive Control1 Intervention
Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual chromoendoscopy
2015
N/A
~2210
Find a Location
Who is running the clinical trial?
Maastricht University Medical CenterOTHER
974 Previous Clinical Trials
3,301,692 Total Patients Enrolled
4 Trials studying Colitis
5,799 Patients Enrolled for Colitis
Copenhagen University Hospital at HerlevOTHER
119 Previous Clinical Trials
108,008 Total Patients Enrolled
1 Trials studying Colitis
50 Patients Enrolled for Colitis
Universitaire Ziekenhuizen LeuvenLead Sponsor
849 Previous Clinical Trials
1,232,384 Total Patients Enrolled
7 Trials studying Colitis
1,119 Patients Enrolled for Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had colorectal cancer in the past.I am under 18 years old.I have had ulcerative colitis for over 8 years, or over 10 years if it started on the left side.I have active ulcerative colitis affecting a large area.I am unable or unwilling to give informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: PENTX i-scan
- Group 2: OLYMPUS CHROMO
- Group 3: OLYMPUS NBI
- Group 4: FUJINON CHROMO
- Group 5: FUJINON FICE
- Group 6: PENTAX CHROMO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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