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

Trial Summary

What is the purpose of this trial?

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. 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 imaging techniques. Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system. These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.

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 data supports the effectiveness of endoscopic imaging techniques for ulcerative colitis treatment?

Research shows that advanced endoscopic imaging techniques, like Fujinon Intelligent Chromo-Endoscopy (FICE), improve the detection of lesions in ulcerative colitis patients compared to standard white light endoscopy. FICE was found to be more accurate in identifying neoplastic (abnormal tissue growth) lesions, which can help in better surveillance and management of the disease. ^{1 2 3 4 5}

Is endoscopic imaging for ulcerative colitis safe?

Endoscopic imaging techniques like chromoendoscopy and narrow-band imaging (NBI) are generally considered safe and easy to perform, with no significant safety concerns reported in the studies. ^{2 5 6 7 8}

How does the treatment Chromoendoscopy differ from other treatments for ulcerative colitis?

Chromoendoscopy, including techniques like Virtual Chromoendoscopy and Narrow-Band Imaging, offers enhanced visualization of the colon's lining by highlighting differences in tissue color and structure, which helps in detecting abnormalities more accurately than standard white light endoscopy. This advanced imaging technique is particularly useful for identifying precancerous changes in patients with ulcerative colitis, improving the accuracy of surveillance and potentially leading to earlier intervention. ^{1 3 4 5 9}

Research Team

Raf Bisschops, MD PhD

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Advanced endoscopic imaging for dysplasia surveillance in ulcerative colitis. [2012]

2. Germany pubmed.ncbi.nlm.nih.gov

Computed image modification for enhancement of small-bowel surface structures at video capsule endoscopy. [2022]

3. Croatia 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Advances in endoscopic imaging in ulcerative colitis. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Modified Kudo classification can improve accuracy of virtual chromoendoscopy with FICE in endoscopic surveillance of ulcerative colitis. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Chromoendoscopy versus narrow band imaging for colonic surveillance in inflammatory bowel disease. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Current status of chromoendoscopy and narrow band imaging in colonoscopy. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Techniques for targeting screening in ulcerative colitis. [2018]