Endoscopic Imaging Techniques for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Raf Bisschops, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Universitaire Ziekenhuizen Leuven

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

No Placebo Group

Approved in 3 Jurisdictions

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.

Trial 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 (Procedure)
• Virtual chromoendoscopy (Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McGill University Health Center Montreal, Canada

Who Is Running the Clinical Trial?

Universitaire Ziekenhuizen Leuven

Lead Sponsor

Trials

850

Patients Recruited

1,233,000+

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

Trials

1048

Patients Recruited

1,658,000+

Maastricht University Medical Center

Collaborator

Trials

992

Patients Recruited

3,304,000+

Copenhagen University Hospital at Herlev

Collaborator

Trials

123

Patients Recruited

109,000+

H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.

Collaborator

Trials

1

Patients Recruited

400+

McGill University

Collaborator

Trials

421

Patients Recruited

1,017,000+

References

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

Advanced endoscopic imaging for dysplasia surveillance in ulcerative colitis. [2012] Ulcerative colitis is a well-characterized chronic inflammatory bowel disease with a significantly increased risk for developing colorectal neoplasia. A rigorous colonoscopy surveillance program has been shown to undoubtedly reduce this risk. White light endoscopy with random 4-quadrant biopsies in addition to target biopsies of suspicious lesions has been considered the standard of care. However, interval cancers between successive surveillance colonoscopies have been identified. Recently, multiple new endoscopic imaging technologies such as standard chromoendoscopy with methylene blue, virtual chromoendoscopy, autofluorescence imaging, confocal laser endomicroscopy and endocytoscopy were developed to provide a more detailed visualization of the mucosa by enhancing morphology and vascularization. This review will provide a comprehensive approach to advanced endoscopic imaging useful for dysplasia surveillance in longstanding ulcerative colitis patients.

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

Computed image modification for enhancement of small-bowel surface structures at video capsule endoscopy. [2022] Computed virtual chromoendoscopy with the Fujinon intelligent color-enhancement (FICE) system was reported to improve visualization of neoplastic and non-neoplastic lesions at gastroscopy and colonoscopy. The technique is based on narrowing the bandwidth of the conventional endoscopic image arithmetically by a spectral estimation technology. Implementation of the FICE software in the video capsule workstation might also allow for contrast-enhanced assessment of nature and extent of small-bowel mucosal lesions. Here we propose this novel technique and report on 10 consecutive patients who underwent small-bowel video capsule endoscopy that was evaluated with FICE-enhanced imaging.

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] To determine which flexible spectral imaging color enhancement (FICE) channel best visualizes colon mucosa in ulcerative colitis (UC) and to compare FICE imaging with standard imaging.

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

Advances in endoscopic imaging in ulcerative colitis. [2015] Modern strategies for the treatment of ulcerative colitis require more accurate tools for gastrointestinal imaging to better assess mucosal disease activity and long-term prognostic clinical outcomes. Recent advances in gastrointestinal luminal endoscopy are radically changing the role of endoscopy in every-day clinical practice and research trials. Advanced endoscopic imaging techniques including high-definition endoscopes, optical magnification endoscopy, and various chromoendoscopy techniques have remarkably improved endoscopic assessment of ulcerative colitis. More recently, optical biopsy techniques with either endocytoscopy or confocal laser endomicroscopy have shown great potential in predicting several histological changes in real time during ongoing endoscopy. Here, we review current applications of advanced endoscopic imaging techniques in ulcerative colitis and present the most promising upcoming headways in this field.

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] Background and study aims  Virtual chromoendoscopy with Fuji Intelligent Color Enhancement (FICE) has never been studied in prospective trials of endoscopic surveillance for ulcerative colitis (UC). We compared FICE and white light endoscopy (WLE) in differentiation of visible lesions in UC. Patients and methods  In a prospective parallel study, we compared consecutive outpatients with UC submitted to surveillance colonoscopy with FICE or WLE. At least one visible polypoid or non-polypoid lesion for each patient was required. Random biopsies from normal mucosa, targeted biopsies or removal of suspected neoplastic lesions and targeted biopsies of unsuspected lesions were performed. In the FICE arm, neoplasia was suspected according to a modified Kudo classification (FICE-KUDO/inflammatory bowel disease [IBD]). Sensitivity (SE), specificity (SP), positive and negative likelihood ratios (LR) and negative predictive value (NPV) were analyzed. Results  One hundred patients were submitted to FICE (n = 46) or WLE (n = 54). Twenty-two patients (11 in WLE, 11 in FICE) had a least one neoplastic lesion. No neoplasia was found in random biopsies. Among 275 lesions, 17 of 136 by FICE and 27 of 139 by WLE were suspected neoplasia, but 28 (14 in each arm) were true neoplastic lesions. The accuracy of FICE-KUDO/IBD vs WLE (per lesion) was: SE 93 % vs 64 % ( P  = 0.065), SP 97 % vs 86 % ( P  = 0.002), positive-LR 28.3 vs 4.5 ( P  = 0.001), negative-LR 0.07 vs 0.42 ( P  = 0.092), NPV 99 % vs 96 % ( P  = 0.083). FICE-KUDO/IBD detected more non-polypoid lesions than WLE ( P  = 0.016). Conclusions  Targeted biopsies of polypoid and non-polypoid lesions, using the modified Kudo classification with FICE are more accurate than WLE in UC surveillance.

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

Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. [2022] 1 ESGE suggests the routine use of high definition white-light endoscopy systems for detecting colorectal neoplasia in average risk populations (weak recommendation, moderate quality evidence). 2 ESGE recommends the routine use of high definition systems and pancolonic conventional or virtual (narrow band imaging [NBI], i-SCAN) chromoendoscopy in patients with known or suspected Lynch syndrome (strong recommendation, low quality evidence). 2b ESGE recommends the routine use of high definition systems and pancolonic conventional or virtual (NBI) chromoendoscopy in patients with known or suspected serrated polyposis syndrome (strong recommendation, low quality evidence). 3 ESGE recommends the routine use of 0.1 % methylene blue or 0.1 % - 0.5 % indigo carmine pancolonic chromoendoscopy with targeted biopsies for neoplasia surveillance in patients with long-standing colitis. In appropriately trained hands, in the situation of quiescent disease activity and adequate bowel preparation, nontargeted, four-quadrant biopsies can be abandoned (strong recommendation, high quality evidence). 4 ESGE suggests that virtual chromoendoscopy (NBI, FICE, i-SCAN) and conventional chromoendoscopy can be used, under strictly controlled conditions, for real-time optical diagnosis of diminutive (≤ 5 mm) colorectal polyps to replace histopathological diagnosis. The optical diagnosis has to be reported using validated scales, must be adequately photodocumented, and can be performed only by experienced endoscopists who are adequately trained and audited (weak recommendation, high quality evidence). 5 ESGE suggests the use of conventional or virtual (NBI) magnified chromoendoscopy to predict the risk of invasive cancer and deep submucosal invasion in lesions such as those with a depressed component (0-IIc according to the Paris classification) or nongranular or mixed-type laterally spreading tumors (weak recommendation, moderate quality evidence).

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

Chromoendoscopy versus narrow band imaging for colonic surveillance in inflammatory bowel disease. [2018] Mucosal dye spraying (chromoendoscopy [CE]) has been shown in controlled studies to enhance lesion detection in colitis surveillance. Narrow band imaging (NBI) potentially offers a more convenient mode of highlighting mucosal lesions. The primary objectives of this study were to compare CE and NBI in colitis surveillance with respect to lesion detection. A secondary objective was to assess the accuracy of the mucosal pit pattern (Kudo classification) with NBI in predicting mucosal histology.

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

Current status of chromoendoscopy and narrow band imaging in colonoscopy. [2021] Colonoscopy, the preferred procedure for colon cancer screening, has well-documented limitations. To improve colonoscopy's effectiveness, augmented endoscopy techniques, such as chromoendoscopy and narrow band imaging (NBI) have been evaluated. Both techniques are inexpensive, safe, and relatively easy to perform. Chromoendoscopy has an increasingly important role in surveillance of IBD, but significant work is needed to determine the optimal staining techniques and mucosal surface pattern analysis before this technique can be incorporated into routine clinical practice. NBI is a much newer technology with far less data. Well-designed prospective randomized controlled trials have failed to identify a benefit of NBI in screening colonoscopy, in surveillance for high-risk populations or as an adjunct for therapeutic procedures.

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

Techniques for targeting screening in ulcerative colitis. [2018] Patients with longstanding chronic ulcerative colitis are "at risk" of developing colorectal cancer. Approximately 1 in 6 patients will die as a result of colorectal malignancy, which can often be difficult to detect using conventional "white light" colonoscopy. New endoscopic techniques and technologies including the use of dye sprays, "chromoendoscopy", high magnification chromoscopic colonoscopy and recently chromoscopic assisted confocal laser scanning in vivo endomicroscopy have now been introduced to improve the diagnostic yield of intraepithelial neoplasia at screening colonoscopy. This review details the true "risk" of colorectal cancer complicating ulcerative colitis, discusses the objective evidence to support current endoscopic screening guidelines, and describes the imminent technological paradigm shift about to occur in the endoscopic management and detection of intraepithelial neoplasia.