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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:
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I have active ulcerative colitis affecting a large area.
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I have had colorectal cancer in the past.
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I am unable or unwilling to give informed consent.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy for reporting.

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
980 Previous Clinical Trials
3,301,718 Total Patients Enrolled
4 Trials studying Colitis
5,699 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
1,232,525 Total Patients Enrolled
7 Trials studying Colitis
1,119 Patients Enrolled for Colitis
Universitaire Ziekenhuizen KU LeuvenLead Sponsor
1,028 Previous Clinical Trials
1,650,362 Total Patients Enrolled
7 Trials studying Colitis
1,119 Patients Enrolled for Colitis
H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.UNKNOWN
McGill UniversityOTHER
414 Previous Clinical Trials
1,018,278 Total Patients Enrolled
2 Trials studying Colitis
115 Patients Enrolled for Colitis
Raf Bisschops, MD PhDPrincipal InvestigatorUniversitaire Ziekenhuizen KU Leuven
3 Previous Clinical Trials
2,459 Total Patients Enrolled
1 Trials studying Colitis
243 Patients Enrolled for Colitis

Media Library

Chromoendoscopy Clinical Trial Eligibility Overview. Trial Name: NCT01882205 — N/A
Colitis Research Study Groups: PENTX i-scan, OLYMPUS CHROMO, OLYMPUS NBI, FUJINON CHROMO, FUJINON FICE, PENTAX CHROMO
Colitis Clinical Trial 2023: Chromoendoscopy Highlights & Side Effects. Trial Name: NCT01882205 — N/A
Chromoendoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01882205 — N/A
~23 spots leftby Dec 2025
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