Endoscopic Imaging Techniques for Ulcerative Colitis

Recruiting at 4 trial locations

Overseen By Hilde Willekens

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Universitaire Ziekenhuizen Leuven

Disqualifiers: Active ulcerative colitis, Colorectal cancer, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

402 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new endoscopic imaging techniques for individuals with longstanding ulcerative colitis, a condition that inflames the colon. The goal is to determine if these new methods match or surpass current techniques in detecting potentially cancerous changes. Participants will be divided into groups to compare different imaging methods, such as chromoendoscopy and newer virtual chromoendoscopy techniques. Individuals who have had ulcerative colitis for over 8 years and underwent surveillance endoscopy more than a year ago may be suitable candidates. As an unphased study, this trial provides a unique opportunity to advance medical knowledge and improve future diagnostic techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these endoscopic imaging techniques are safe for ulcerative colitis patients?

Research has shown that the new endoscopic imaging techniques being tested for ulcerative colitis are generally easy for patients to handle. Narrow-Band Imaging (NBI) performs as well as chromo-endoscopy, which is currently the best available method. NBI is also quicker and easier to use, making it appealing for both doctors and patients.

The Fujinon Intelligent Chromo-Endoscopy (FICE) and Pentax I-scan systems enhance images, helping doctors see changes in the colon more clearly. Other studies have used these techniques without any serious safety issues.

While these new methods appear promising, they have not been specifically proven for ulcerative colitis yet. However, their inclusion in a trial suggests they are considered safe enough for further investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these endoscopic imaging techniques for ulcerative colitis because they offer potential improvements in detecting and assessing inflammation and lesions in the colon. Unlike traditional colonoscopy methods, virtual chromoendoscopy options like PENTX i-scan, OLYMPUS NBI, and FUJINON FICE use advanced imaging technologies to enhance visualization without the need for dyes, making the procedure more comfortable for patients. Meanwhile, methods like OLYMPUS CHROMO, FUJINON CHROMO, and PENTAX CHROMO still use chromo-endoscopy with methylene blue but rely on high-definition and specialized equipment to provide clearer images. These advancements could lead to more accurate diagnosis and better management of ulcerative colitis.

What evidence suggests that these endoscopic imaging techniques are effective for detecting neoplastic lesions in ulcerative colitis patients?

Research has shown that chromo-endoscopy, one of the techniques studied in this trial, is the best method for detecting potentially cancerous growths in individuals with long-term ulcerative colitis. Studies have found that this technique reduces the number of tissue samples needed while identifying more growths than traditional methods. Participants in this trial may also receive Narrow-Band Imaging (NBI), which uses specific light to detect growths as effectively as chromo-endoscopy but is faster and easier to use. The Fujinon Intelligent Chromo-Endoscopy (FICE) and Pentax I-scan systems, also tested in this trial, enhance images using computer technology, offering similar benefits. These virtual chromoendoscopy methods may improve screening efficiency for ulcerative colitis patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Raf Bisschops, MD PhD

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Previous surveillance endoscopy > 1 year

I have had ulcerative colitis for over 8 years, or over 10 years if it started on the left side.

Signed informed consent form

Exclusion Criteria

Allergy or intolerance to methylene blue

Pregnant women

I have had colorectal cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endoscopic Procedure

Participants undergo endoscopic procedures using different imaging techniques to detect neoplastic lesions.

1 day

1 visit (in-person)

Pathology Assessment

Pathology results are assessed to determine the presence of neoplastic lesions.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the endoscopic procedure.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chromoendoscopy
• Virtual chromoendoscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: PENTX i-scan Experimental Treatment 1 Intervention

Group F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings

Group II: OLYMPUS NBI Experimental Treatment 1 Intervention

Group B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)

Group III: FUJINON FICE Experimental Treatment 1 Intervention

Group D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4

Group IV: OLYMPUS CHROMO Active Control 1 Intervention

Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%

Group V: FUJINON CHROMO Active Control 1 Intervention

Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%

Group VI: PENTAX CHROMO Active Control 1 Intervention

Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%

Chromoendoscopy is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Chromoendoscopy for:

• Detection of neoplastic lesions in ulcerative colitis
• Surveillance colonoscopy in inflammatory bowel disease

Approved in United States as Chromoendoscopy for:

• Detection of dysplasia in inflammatory bowel disease
• Surveillance colonoscopy in ulcerative colitis

Approved in United Kingdom as Chromoendoscopy for:

• Detection of neoplastic lesions in ulcerative colitis
• Surveillance colonoscopy in inflammatory bowel disease

Who Is Running the Clinical Trial?

Universitaire Ziekenhuizen Leuven

Lead Sponsor

Trials

850

Recruited

1,233,000+

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

Trials

1,048

Recruited

1,658,000+

Maastricht University Medical Center

Collaborator

Trials

992

Recruited

3,304,000+

Copenhagen University Hospital at Herlev

Collaborator

Trials

123

Recruited

109,000+

H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.

Collaborator

Trials

1

Recruited

400+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Published Research Related to This Trial

Advanced endoscopic imaging techniques, such as high-definition endoscopes and optical magnification, have significantly improved the ability to assess mucosal disease activity in ulcerative colitis, enhancing clinical practice and research.

New optical biopsy methods, like endocytoscopy and confocal laser endomicroscopy, show promise in predicting histological changes in real time, potentially leading to better management and outcomes for patients with ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in endoscopic imaging in ulcerative colitis. Tontini, GE., Pastorelli, L., Ishaq, S., et al.[2015]

The Fujinon intelligent color-enhancement (FICE) system improves the visualization of both neoplastic and non-neoplastic lesions during gastroscopy and colonoscopy, enhancing diagnostic accuracy.

In a study involving 10 patients, the implementation of FICE in small-bowel video capsule endoscopy may allow for better contrast and assessment of mucosal lesions, suggesting a promising advancement in gastrointestinal imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed image modification for enhancement of small-bowel surface structures at video capsule endoscopy. Pohl, J., Aschmoneit, I., Schuhmann, S., et al.[2022]

In a study involving 44 patients with chronic colitis, chromoendoscopy (CE) was found to identify significantly more lesions than narrow band imaging (NBI), with 131 lesions detected by CE compared to 102 by NBI.

While both methods detected neoplastic lesions, CE showed a nonsignificant trend towards better detection of dysplastic lesions, indicating that NBI is not currently recommended as a substitute for CE in dysplasia surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chromoendoscopy versus narrow band imaging for colonic surveillance in inflammatory bowel disease. Efthymiou, M., Allen, PB., Taylor, AC., et al.[2018]

In a study of 100 patients with ulcerative colitis, virtual chromoendoscopy using Fuji Intelligent Color Enhancement (FICE) demonstrated higher sensitivity (93% vs 64%) and specificity (97% vs 86%) compared to white light endoscopy (WLE) for detecting neoplastic lesions.

FICE was particularly effective in identifying non-polypoid lesions, suggesting it may be a superior method for surveillance in ulcerative colitis compared to traditional WLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Kudo classification can improve accuracy of virtual chromoendoscopy with FICE in endoscopic surveillance of ulcerative colitis. Cassinotti, A., Fociani, P., Duca, P., et al.[2020]

Regular colonoscopy surveillance significantly reduces the risk of colorectal cancer in patients with ulcerative colitis, a chronic inflammatory bowel disease.

New advanced endoscopic imaging technologies, such as chromoendoscopy and autofluorescence imaging, enhance the visualization of the intestinal mucosa, potentially improving the detection of dysplasia and interval cancers during surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced endoscopic imaging for dysplasia surveillance in ulcerative colitis. Bessissow, T., Bisschops, R.[2012]

The European Society of Gastrointestinal Endoscopy (ESGE) recommends using high-definition white-light endoscopy for detecting colorectal neoplasia in average-risk populations, based on moderate quality evidence, indicating its effectiveness in routine screenings.

For patients with known or suspected Lynch syndrome or serrated polyposis syndrome, ESGE strongly recommends the use of high-definition systems and pancolonic chromoendoscopy, highlighting the importance of advanced imaging techniques in these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Kamiński, MF., Hassan, C., Bisschops, R., et al.[2022]

In a study involving 18 patients with ulcerative colitis, flexible spectral imaging color enhancement (FICE) effectively visualized different colon mucosa types, with the second and ninth FICE channels showing the best results for assessing normal mucosa and colitis areas.

While FICE did not significantly improve dysplasia detection compared to standard imaging, it was useful for identifying diminutive polyps and evaluating inflammation severity in patients with ulcerative colitis in remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of colon mucosa using screening colonoscopy and flexible spectral imaging color enhancement in patients with long lasting ulcerative colitis. Özdinç, SA., Akpinar, H., Bengi, G., et al.[2021]

Patients with longstanding chronic ulcerative colitis have a significant risk of developing colorectal cancer, with about 1 in 6 patients potentially dying from this malignancy, highlighting the importance of effective screening.

New advanced endoscopic techniques, such as chromoendoscopy and confocal laser scanning, are being introduced to enhance the detection of early cancerous changes in the colon, which could lead to better outcomes for patients at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for targeting screening in ulcerative colitis. Hurlstone, DP., Brown, S.[2018]

Chromoendoscopy is a promising technique for improving colonoscopy effectiveness, especially in monitoring inflammatory bowel disease (IBD), but further research is needed to refine staining methods and mucosal analysis before it can be widely adopted.

Narrow band imaging (NBI) has not shown any significant benefits in enhancing screening colonoscopy or in high-risk surveillance, according to well-designed randomized controlled trials, indicating that its efficacy remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of chromoendoscopy and narrow band imaging in colonoscopy. Nass, JP., Connolly, SE.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01882205

NCT01882205 | Comparison Between Chromoendoscopy ... The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8826039/

Electronic chromo-endoscopy: technical details and a clinical ... Electronic or virtual chromo-endoscopy (ECE) is an alternative to conventional dye-based chromo-endoscopy which markedly improves capillary pattern.

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/77260

Comparison Between Chromoendoscopy and Virtual ... Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1542356524010735

Comparative Efficacy and Safety of Endoscopic Modalities ... HD dye-based chromoendoscopy may improve dysplasia detection compared with other modalities like HD white light endoscopy, although evidence certainty is low.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511918/

A Novel Switching of Artificial Intelligence to Generate ... Virtual Chromoendoscopy (VCE) is pivotal for assessing activity and predicting outcomes in Ulcerative Colitis (UC), though interobserver variability and the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4962681/

Chromoendoscopy and Dysplasia Surveillance in ... In this article, we discuss the various techniques currently available for dysplasia surveillance in IBD, with a focus on chromoendoscopy.

7. cghjournal.org cghjournal.org/article/S1542-3565(16)31119-3/fulltext

Chromoendoscopy for Surveillance in Ulcerative Colitis ... Pooled data from existing low-quality randomized trials showed no difference between chromoendoscopy and high-definition white-light endoscopy, ...