Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)CLEAR-IBDNCT07694362
Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease
A study testing ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device) in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Ulcerative Colitis (UC), run by Vall d'Hebron Institute Research at 1 site in Spain.
Trial summary
Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Ulcerative Colitis (UC), Crohn's Disease Colon
- What is being tested?
- ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with IBD, scheduled for endoscopic colorectal cancer surveillance following the ECCO guidelines.
- ≥ 18 years-old.
- At least 8 year duration ulcerative colitis (UC) or colonic Crohn's disease (CD) unless in case of concomitant primary sclerosing cholangitis which any disease duration was eligible for screening colonoscopy.
Who cannot join
- Inadequate bowel preparation (Boston Bowel Preparation Scale < 6).
- The presence of any degree of endoscopic inflammation or technical reasons that prevented completion of colonoscopy, such as a critical stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease: a Prospective, Randomized, Crossover Study The CLEAR-IBD Trial (Colorectal Lesion Evaluation Assisted by Real-time AI in Inflammatory Bowel Disease)
Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can develop into cancer over time.
Finding these abnormal areas during colonoscopy can be difficult because IBD causes ongoing inflammation that can make the bowel mucosa look irregular, hiding subtle changes. Doctors currently use a technique called narrow-band imaging (NBI), a special light setting on the colonoscope that enhances the visibility of the bowel, to help spot these areas more easily.
Read more
A newer tool, artificial intelligence (AI)-assisted detection, has shown promise in helping doctors find more polyps during routine colonoscopies in the general population. However, this AI tool was developed and tested mostly in people without IBD, so it is not yet known whether it works as well in people with IBD, whose bowel can look very different due to chronic inflammation.
This study will directly compare the AI tool (CADe; ENDO-AID, Olympus) with narrow-band imaging to see which one is better at finding abnormal areas during colonoscopy in patients with long-standing ulcerative colitis or Crohn's disease who are having their routine cancer surveillance exam.
Each participant will have one colonoscopy in which the bowel is examined twice in a row, once with each technique, by two different doctors, in random order. This lets researchers compare both methods directly within the same patient, which is the fairest comparison.
The study aims to enroll 60 patients at Vall d'Hebron University Hospital in Barcelona, Spain. Researchers hope the results will help determine whether AI tools - which are widely available and easier to use than NBI - can be a reliable alternative for IBD surveillance, potentially making this important cancer-screening exam more accessible in the future.
Read the detailed description
Background and Rationale
Patients with inflammatory bowel disease (IBD) remain at increased risk of colorectal cancer (CRC) compared with the general population, and colonoscopic surveillance has been shown to reduce both CRC incidence and CRC-related mortality. Although high-definition dye-based chromoendoscopy is recommended by most guidelines as the surveillance technique of choice, its uptake remains limited due to training requirements, added procedure time, and cost. As a result, several guidelines continue to accept virtual chromoendoscopy techniques, including narrow-band imaging (NBI), and high-definition white-light endoscopy as alternatives.
Computer-aided detection (CADe) systems based on artificial intelligence have demonstrated meaningful improvements in adenoma and polyp detection in non-IBD populations. However, the convolutional neural network-based algorithms underlying these systems have largely been trained on datasets that excluded patients with IBD, so the real-world performance of currently available non-IBD-trained CADe systems for detecting colitis-associated dysplasia remains unknown. Existing evidence in this area has relied mainly on retrospective analyses of still-image datasets, without prospective, real-time comparison against validated comparators such as chromoendoscopy or NBI. A direct, prospective comparison is therefore needed.
Study Design This is a unicentric, two-arm, open-label, randomized, crossover clinical trial conducted at the IBD Clinic of the Gastroenterology Department, Vall d'Hebron University Hospital, Barcelona, Spain. Each participant undergoes a single colonoscopy in which the entire colon is examined twice, consecutively, by two different endoscopists using the two study techniques (CADe and NBI) in randomized order, allowing each patient to act as their own control and minimizing between-patient confounding.
Study Procedures Each participant is examined on the same day by two endoscopists with expertise in IBD endoscopic surveillance. Endoscopist 1 examines the entire colon using either AI (ENDO-AID CADe System, Olympus, Tokyo, Japan) or NBI, per the randomization sequence. Before lesion assessment, endoscopic remission is confirmed using the Mayo endoscopic score (UC) or the Simple Endoscopic Score for Crohn's Disease (SES-CD), requiring a score of 0. Lesions identified are documented and managed accordingly (resection or biopsy). Endoscopist 2, blinded to the findings of Endoscopist 1, re-examines the entire colon using the alternate technique, documents any additional findings, and manages any lesions missed during the first examination. Both endoscopists perform an equal number of examinations with each technique as the first or second pass, and all procedures use the same high-definition endoscope and processor (Olympus CF-HQ190L, EVIS X1).
All lesions resected or biopsied, regardless of detection order, are categorized using the Paris classification, with location and size recorded. Specimens are assessed by pathologists with expertise in IBD as part of standard care; adenocarcinoma, serrated adenoma, tubular adenoma, and any dysplasia are classified as neoplastic lesions. Biopsies are systematically obtained from previously identified colitic segments in all patients to assess the impact of histological inflammatory activity on neoplasia detection. Withdrawal time, defined as the interval between the start of inspection at the cecum and the end of the procedure, is recorded separately for each technique and examination order.
Randomization and Blinding Patients are consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm, with allocation performed by Endoscopist 1 prior to the procedure. Blinding of endoscopists to the technique itself is not feasible given that the AI overlay is visible on screen; however, Endoscopist 2 remains blinded to the findings of the first examination, preserving the integrity of the tandem comparison.
Data Collection Patient and disease characteristics collected include age, sex, IBD type, age at diagnosis, disease location and behavior (Montreal classification for CD; extent for UC), presence of perianal disease, presence of primary sclerosing cholangitis, current and past medication, personal history of dysplasia, previous IBD-related surgery, and time elapsed since the last surveillance colonoscopy. Procedural data collected include the randomization arm, order of techniques, all detected lesions (technique, endoscopist, morphology, size, location), histological findings, withdrawal times, and any procedure-related complications.
Sample Size and Statistical Analysis In the absence of prior data on CADe performance in IBD surveillance colonoscopy, the sample size was pragmatically set at 60 evaluable patients, based on previously published crossover studies comparing dye-based chromoendoscopy and NBI in this population. A 20% dropout rate was anticipated to account for incomplete explorations, withdrawal of consent, and suboptimal bowel preparation, so recruitment was planned for approximately 72 patients. Lesion-level detection (paired binary outcomes) will be compared using the McNemar test, while per-patient dysplastic lesion counts will be compared using the Wilcoxon signed-rank test. Because most lesions are sampled immediately upon detection, only missed or unresected lesions can be identified during the second examination, precluding fully paired analyses for some comparisons; individual lesions are therefore treated as statistically independent observations in those cases. Quantitative variables are compared using Student's t-test or the Mann-Whitney U test as appropriate, and proportions using the χ² test or Fisher's exact test, with Bonferroni correction applied for multiple comparisons involving lesion location and histology. All p-values are two-sided, with p < 0.05 considered statistically significant. Analyses are performed using SPSS version 16 (SPSS Inc., Chicago, IL).
Ethical and Regulatory Considerations This protocol was approved by the Drug Research Ethics Committee (Comité de Ética de la Investigación con Medicamentos) of Hospital Universitari Vall d'Hebron under code PR(AG)237/2023. All participants provide written informed consent prior to enrolment, and the study is conducted in accordance with the Declaration of Helsinki and applicable national and institutional regulations. No patients or members of the public were involved in the design, conduct, reporting, or dissemination of this research. Any immediate or delayed procedure-related complications are recorded and reported according to institutional adverse event monitoring protocols.
Funding This work is supported by the Societat Catalana de Digestologia through the Ajut per a la Iniciació a la Recerca grant. The funder has no role in study design, data collection, analysis, interpretation, or manuscript decisions. The investigators declare no relevant conflicts of interest.
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Ulcerative Colitis (UC), Crohn's Disease Colon, Colonic Dysplasia/Adenomata, Artificial Intelligence (AI), NBI
- Being tested
- ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)
- Keywords
- Inflammatory Bowel Disease, Narrow Band Imaging (NBI), Chromoendoscopy, Colonic Dysplasia, Surveillance, Artificial Intelligence (AI)
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)Device
Also called Narrow Band Imaging (NBI)
Each participant was examined by two endoscopists with expertise in endoscopic surveillance in IBD on the same day consecutively in a randomized manner. Both endoscopists alternated between AI and NBI. Endoscopist 1 evaluated the entire colon using either AI -ENDO-AID CADe System (Olympus, Tokyo, Japan)- or NBI. Before lesion assessment, Endoscopist 1 first confirmed endoscopic remission, defined as a Mayo endoscopic score and a Simple Endoscopic Score for Crohn's Disease (SES-CD) for UC and CD, respectively, of 0. Then, lesions were documented and managed accordingly - resection or biopsy. Endoscopist 2, blinded to the previous findings, re-examined the entire colon with the alternate method, documented additional findings, and treated any lesions missed by Endoscopist 1. Both endoscopists performed the same number of explorations with NBI and AI as first or second exploration. High-definition endoscopes and the same processor were used for all procedures (Olympus CF-- HQ19).
| Study group | Role | What they receive |
|---|---|---|
| NBI first followed by AI | Experimental | Patients were consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm. Allocation was performed prior to the procedure by endoscopist 1. Blinding was not feasible owing to the nature of the intervention. Receives: Device: ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device) |
| AI first followed by NBI | Experimental | Patients were consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm. Allocation was performed prior to the procedure by endoscopist 1. Blinding was not feasible owing to the nature of the intervention. Receives: Device: ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neoplasia miss rate (NMR) assessed in a per-lesion analysis
Calculated as the number of neoplastic lesions missed during the first examination and detected on the second examination, divided by the total number of neoplastic lesions detected across both examinations.
Measured: Periprocedural.
Secondary outcomes (7)
Neoplasia miss rate (NMR) evaluated in a per-patient analysis
Defined as the number of patients with at least one neoplastic lesion missed during the first examination and detected on the second examination, divided by the total number of unique patients with at least one neoplastic lesion detected across both examinations
Measured: Periprocedural.
Withdrawal time
Time from cecal intubation to colonoscope withdrawal, including therapeutic maneuvers.
Measured: Periprocedural.
Degree of histological inflammatory activity
Histological inflammatory activity will be graded using the Nancy Histological Index, applied to biopsies systematically obtained from previously identified colitic segments.
Measured: Periprocedural.
Rate of colorectal neoplasia detection
Proportion of biopsied or resected lesions classified as neoplastic (adenocarcinoma, serrated adenoma, tubular adenoma, or dysplasia) on histopathological assessment, stratified by Nancy Histological Index grade.
Measured: Periprocedural.
Size of detected neoplastic lesions, by detection technique
Maximum lesion diameter, measured endoscopically in millimeters, will be recorded for each neoplastic lesion and compared between lesions detected by CADe and lesions detected by NBI.
Measured: Periprocedural.
Morphological classification of detected neoplastic lesions, by detection technique
Lesion morphology will be classified according to the Paris classification and compared between lesions detected by CADe and lesions detected by NBI.
Measured: Periprocedural.
Histological classification of detected neoplastic lesions, by detection technique
Lesions will be histologically classified (e.g., tubular adenoma, serrated adenoma, adenocarcinoma, or other dysplasia) by pathologists with expertise in IBD, and compared between lesions detected by CADe and lesions detected by NBI.
Measured: Periprocedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jan 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant was examined by two endoscopists with expertise in endoscopic surveillance in IBD on the same day consecutively in a randomized manner. Both endoscopists alternated between AI and NBI. Endoscopist 1 evaluated the entire colon using either AI -ENDO-AID CADe System (Olympus, Tokyo, Japan)- or NBI. Before lesion assessment, Endoscopist 1 first confirmed endoscopic remission, defined as a Mayo endoscopic score and a Simple Endoscopic Score for Crohn's Disease (SES-CD) for UC and CD, respectively, of 0. Then, lesions were documented and managed accordingly - resection or biopsy. Endoscopist 2, blinded to the previous findings, re-examined the entire colon with the alternate method, documented additional findings, and treated any lesions missed by Endoscopist 1. Both endoscopists performed the same number of explorations with NBI and AI as first or second exploration. High-definition endoscopes and the same processor were used for all procedures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute Research
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Digestologia
- Responsible party
- Sponsor
- Investigators
- Natalia Borruel, MD, PhD, Study chair, Vall d'Hebron University Hospital, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694362
- Sponsor's protocol ID
- CLEAR-IBD
- Acronym
- CLEAR-IBD
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data underlying this article will be shared on reasonable request to the corresponding author.
Publications
Simmons DT, Harewood GC, Baron TH, Petersen BT, Wang KK, Boyd-Enders F, Ott BJ. Impact of endoscopist withdrawal speed on polyp yield: implications for optimal colonoscopy withdrawal time. Aliment Pharmacol Ther. 2006 Sep 15;24(6):965-71. doi: 10.1111/j.1365-2036.2006.03080.x.
PubMed 16948808Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
PubMed 17167136Rex DK, Bond JH, Winawer S, Levin TR, Burt RW, Johnson DA, Kirk LM, Litlin S, Lieberman DA, Waye JD, Church J, Marshall JB, Riddell RH; U.S. Multi-Society Task Force on Colorectal Cancer. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002 Jun;97(6):1296-308. doi: 10.1111/j.1572-0241.2002.05812.x. No abstract available.
PubMed 12094842van den Broek FJ, Kuiper T, Dekker E, Zwinderman AH, Fockens P, Reitsma JB. Study designs to compare new colonoscopic techniques: clinical considerations, data analysis, and sample size calculations. Endoscopy. 2013 Nov;45(11):922-7. doi: 10.1055/s-0033-1344434. Epub 2013 Aug 5.
PubMed 23918622Te Groen M, Wijnands AM, den Broeder N, de Jong DJ, van Dop WA, Duijvestein M, Fidder HH, van Schaik F, Hirdes MMC, van der Meulen-de Jong AE, Maljaars PWJ, Voorneveld PW, de Boer KHN, Peters CP, Oldenburg B, Hoentjen F; Dutch Initiative on Crohn and Colitis. Surveillance in inflammatory bowel disease: white light endoscopy with segmental re-inspection versus dye-based chromoendoscopy - a multi-arm randomised controlled trial (HELIOS). Gut. 2025 Mar 6;74(4):547-556. doi: 10.1136/gutjnl-2024-333446.
PubMed 39819862Sinopoulou V, Nigam GB, Gordon M, Ganeshan M, Tokonyai MR, Dolwani S, Iacucci M, Rutter M, Subramanian V, Wilson A, East JE; British Society of Gastroenterology Colorectal IBD Surveillance Guideline Development Group. Comparative Efficacy and Safety of Endoscopic Modalities for Colorectal Cancer Screening in Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2128-2143. doi: 10.1016/j.cgh.2024.11.008. Epub 2024 Dec 13.
PubMed 39675405Hassan C, Rizkala T, Mori Y, Spadaccini M, Misawa M, Antonelli G, Rondonotti E, Dekker E, Houwen BBSL, Pech O, Baumer S, Li JW, von Renteln D, Haumesser C, Maselli R, Facciorusso A, Correale L, Menini M, Schiliro A, Khalaf K, Patel H, Radadiya DK, Bhandari P, Kudo SE, Sultan S, Vandvik PO, Sharma P, Rex DK, Foroutan F, Repici A; CADx analysis study group. Computer-aided diagnosis for the resect-and-discard strategy for colorectal polyps: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):1010-1019. doi: 10.1016/S2468-1253(24)00222-X. Epub 2024 Sep 17.
PubMed 39303733Abdelrahim M, Siggens K, Iwadate Y, Maeda N, Htet H, Bhandari P. New AI model for neoplasia detection and characterisation in inflammatory bowel disease. Gut. 2024 Apr 5;73(5):725-728. doi: 10.1136/gutjnl-2023-330718. No abstract available.
PubMed 38395438Deepak P, Hanson GJ, Fletcher JG, Tremaine WJ, Pardi DS, Kisiel JB, Schroeder KW, Wong Kee Song LM, Harmsen WS, Loftus EV Jr, Bruining DH. Incremental diagnostic yield of chromoendoscopy and outcomes in inflammatory bowel disease patients with a history of colorectal dysplasia on white-light endoscopy. Gastrointest Endosc. 2016 May;83(5):1005-12. doi: 10.1016/j.gie.2015.09.021. Epub 2015 Sep 25.
PubMed 26408903Leong RW, Ooi M, Corte C, Yau Y, Kermeen M, Katelaris PH, McDonald C, Ngu M. Full-Spectrum Endoscopy Improves Surveillance for Dysplasia in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 May;152(6):1337-1344.e3. doi: 10.1053/j.gastro.2017.01.008. Epub 2017 Jan 23.
PubMed 28126349Marion JF, Waye JD, Present DH, Israel Y, Bodian C, Harpaz N, Chapman M, Itzkowitz S, Steinlauf AF, Abreu MT, Ullman TA, Aisenberg J, Mayer L; Chromoendoscopy Study Group at Mount Sinai School of Medicine. Chromoendoscopy-targeted biopsies are superior to standard colonoscopic surveillance for detecting dysplasia in inflammatory bowel disease patients: a prospective endoscopic trial. Am J Gastroenterol. 2008 Sep;103(9):2342-9. doi: 10.1111/j.1572-0241.2008.01934.x.
PubMed 18844620Efthymiou M, Allen PB, Taylor AC, Desmond PV, Jayasakera C, De Cruz P, Kamm MA. Chromoendoscopy versus narrow band imaging for colonic surveillance in inflammatory bowel disease. Inflamm Bowel Dis. 2013 Sep;19(10):2132-8. doi: 10.1097/MIB.0b013e31829637b9.
PubMed 23899540Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.
PubMed 38740327Rajpurkar P, Lungren MP. The Current and Future State of AI Interpretation of Medical Images. N Engl J Med. 2023 May 25;388(21):1981-1990. doi: 10.1056/NEJMra2301725. No abstract available.
PubMed 37224199Yamamoto S, Kinugasa H, Hamada K, Tomiya M, Tanimoto T, Ohto A, Toda A, Takei D, Matsubara M, Suzuki S, Inoue K, Tanaka T, Hiraoka S, Okada H, Kawahara Y. The diagnostic ability to classify neoplasias occurring in inflammatory bowel disease by artificial intelligence and endoscopists: A pilot study. J Gastroenterol Hepatol. 2022 Aug;37(8):1610-1616. doi: 10.1111/jgh.15904. Epub 2022 Jun 4.
PubMed 35644932
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease: a Prospective, Randomized, Crossover Study The CLEAR-IBD Trial (Colorectal Lesion Evaluation Assisted by Real-time AI in Inflammatory Bowel Disease)
- ClinicalTrials.gov ID
- NCT07694362
- Acronym / sponsor ID
- CLEAR-IBD / CLEAR-IBD
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Ulcerative Colitis (UC), Crohn's Disease Colon, Colonic Dysplasia/Adenomata, Artificial Intelligence (AI), NBI
- Keywords
- Inflammatory Bowel Disease, Narrow Band Imaging (NBI), Chromoendoscopy, Colonic Dysplasia, Surveillance, Artificial Intelligence (AI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vall d'Hebron Institute ResearchUniversity, hospital or other
- Collaborators
- Societat Catalana de Digestologia
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can develop into cancer over time.
Finding these abnormal areas during colonoscopy can be difficult because IBD causes ongoing inflammation that can make the bowel mucosa look irregular, hiding subtle changes. Doctors currently use a technique called narrow-band imaging (NBI), a special light setting on the colonoscope that enhances the visibility of the bowel, to help spot these areas more easily.
A newer tool, artificial intelligence (AI)-assisted detection, has shown promise in helping doctors find more polyps during routine colonoscopies in the general population. However, this AI tool was developed and tested mostly in people without IBD, so it is not yet known whether it works as well in people with IBD, whose bowel can look very different due to chronic inflammation.
This study will directly compare the AI tool (CADe; ENDO-AID, Olympus) with narrow-band imaging to see which one is better at finding abnormal areas during colonoscopy in patients with long-standing ulcerative colitis or Crohn's disease who are having their routine cancer surveillance exam.
Each participant will have one colonoscopy in which the bowel is examined twice in a row, once with each technique, by two different doctors, in random order. This lets researchers compare both methods directly within the same patient, which is the fairest comparison.
The study aims to enroll 60 patients at Vall d'Hebron University Hospital in Barcelona, Spain. Researchers hope the results will help determine whether AI tools - which are widely available and easier to use than NBI - can be a reliable alternative for IBD surveillance, potentially making this important cancer-screening exam more accessible in the future.
Detailed description
Background and Rationale
Patients with inflammatory bowel disease (IBD) remain at increased risk of colorectal cancer (CRC) compared with the general population, and colonoscopic surveillance has been shown to reduce both CRC incidence and CRC-related mortality. Although high-definition dye-based chromoendoscopy is recommended by most guidelines as the surveillance technique of choice, its uptake remains limited due to training requirements, added procedure time, and cost. As a result, several guidelines continue to accept virtual chromoendoscopy techniques, including narrow-band imaging (NBI), and high-definition white-light endoscopy as alternatives.
Computer-aided detection (CADe) systems based on artificial intelligence have demonstrated meaningful improvements in adenoma and polyp detection in non-IBD populations. However, the convolutional neural network-based algorithms underlying these systems have largely been trained on datasets that excluded patients with IBD, so the real-world performance of currently available non-IBD-trained CADe systems for detecting colitis-associated dysplasia remains unknown. Existing evidence in this area has relied mainly on retrospective analyses of still-image datasets, without prospective, real-time comparison against validated comparators such as chromoendoscopy or NBI. A direct, prospective comparison is therefore needed.
Study Design This is a unicentric, two-arm, open-label, randomized, crossover clinical trial conducted at the IBD Clinic of the Gastroenterology Department, Vall d'Hebron University Hospital, Barcelona, Spain. Each participant undergoes a single colonoscopy in which the entire colon is examined twice, consecutively, by two different endoscopists using the two study techniques (CADe and NBI) in randomized order, allowing each patient to act as their own control and minimizing between-patient confounding.
Study Procedures Each participant is examined on the same day by two endoscopists with expertise in IBD endoscopic surveillance. Endoscopist 1 examines the entire colon using either AI (ENDO-AID CADe System, Olympus, Tokyo, Japan) or NBI, per the randomization sequence. Before lesion assessment, endoscopic remission is confirmed using the Mayo endoscopic score (UC) or the Simple Endoscopic Score for Crohn's Disease (SES-CD), requiring a score of 0. Lesions identified are documented and managed accordingly (resection or biopsy). Endoscopist 2, blinded to the findings of Endoscopist 1, re-examines the entire colon using the alternate technique, documents any additional findings, and manages any lesions missed during the first examination. Both endoscopists perform an equal number of examinations with each technique as the first or second pass, and all procedures use the same high-definition endoscope and processor (Olympus CF-HQ190L, EVIS X1).
All lesions resected or biopsied, regardless of detection order, are categorized using the Paris classification, with location and size recorded. Specimens are assessed by pathologists with expertise in IBD as part of standard care; adenocarcinoma, serrated adenoma, tubular adenoma, and any dysplasia are classified as neoplastic lesions. Biopsies are systematically obtained from previously identified colitic segments in all patients to assess the impact of histological inflammatory activity on neoplasia detection. Withdrawal time, defined as the interval between the start of inspection at the cecum and the end of the procedure, is recorded separately for each technique and examination order.
Randomization and Blinding Patients are consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm, with allocation performed by Endoscopist 1 prior to the procedure. Blinding of endoscopists to the technique itself is not feasible given that the AI overlay is visible on screen; however, Endoscopist 2 remains blinded to the findings of the first examination, preserving the integrity of the tandem comparison.
Data Collection Patient and disease characteristics collected include age, sex, IBD type, age at diagnosis, disease location and behavior (Montreal classification for CD; extent for UC), presence of perianal disease, presence of primary sclerosing cholangitis, current and past medication, personal history of dysplasia, previous IBD-related surgery, and time elapsed since the last surveillance colonoscopy. Procedural data collected include the randomization arm, order of techniques, all detected lesions (technique, endoscopist, morphology, size, location), histological findings, withdrawal times, and any procedure-related complications.
Sample Size and Statistical Analysis In the absence of prior data on CADe performance in IBD surveillance colonoscopy, the sample size was pragmatically set at 60 evaluable patients, based on previously published crossover studies comparing dye-based chromoendoscopy and NBI in this population. A 20% dropout rate was anticipated to account for incomplete explorations, withdrawal of consent, and suboptimal bowel preparation, so recruitment was planned for approximately 72 patients. Lesion-level detection (paired binary outcomes) will be compared using the McNemar test, while per-patient dysplastic lesion counts will be compared using the Wilcoxon signed-rank test. Because most lesions are sampled immediately upon detection, only missed or unresected lesions can be identified during the second examination, precluding fully paired analyses for some comparisons; individual lesions are therefore treated as statistically independent observations in those cases. Quantitative variables are compared using Student's t-test or the Mann-Whitney U test as appropriate, and proportions using the χ² test or Fisher's exact test, with Bonferroni correction applied for multiple comparisons involving lesion location and histology. All p-values are two-sided, with p < 0.05 considered statistically significant. Analyses are performed using SPSS version 16 (SPSS Inc., Chicago, IL).
Ethical and Regulatory Considerations This protocol was approved by the Drug Research Ethics Committee (Comité de Ética de la Investigación con Medicamentos) of Hospital Universitari Vall d'Hebron under code PR(AG)237/2023. All participants provide written informed consent prior to enrolment, and the study is conducted in accordance with the Declaration of Helsinki and applicable national and institutional regulations. No patients or members of the public were involved in the design, conduct, reporting, or dissemination of this research. Any immediate or delayed procedure-related complications are recorded and reported according to institutional adverse event monitoring protocols.
Funding This work is supported by the Societat Catalana de Digestologia through the Ajut per a la Iniciació a la Recerca grant. The funder has no role in study design, data collection, analysis, interpretation, or manuscript decisions. The investigators declare no relevant conflicts of interest.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each participant was examined by two endoscopists with expertise in endoscopic surveillance in IBD on the same day consecutively in a randomized manner. Both endoscopists alternated between AI and NBI. Endoscopist 1 evaluated the entire colon using either AI -ENDO-AID CADe System (Olympus, Tokyo, Japan)- or NBI. Before lesion assessment, Endoscopist 1 first confirmed endoscopic remission, defined as a Mayo endoscopic score and a Simple Endoscopic Score for Crohn's Disease (SES-CD) for UC and CD, respectively, of 0. Then, lesions were documented and managed accordingly - resection or biopsy. Endoscopist 2, blinded to the previous findings, re-examined the entire colon with the alternate method, documented additional findings, and treated any lesions missed by Endoscopist 1. Both endoscopists performed the same number of explorations with NBI and AI as first or second exploration. High-definition endoscopes and the same processor were used for all procedures.
| Arm | Type | Receives |
|---|---|---|
| NBI first followed by AI | Experimental | Device: ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)Patients were consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm. Allocation was performed prior to the procedure by endoscopist 1. Blinding was not feasible owing to the nature of the intervention. |
| AI first followed by NBI | Experimental | Device: ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)Patients were consecutively allocated in a 1:1 alternating sequence to either the "NBI first followed by AI" arm or the "AI first followed by NBI" arm. Allocation was performed prior to the procedure by endoscopist 1. Blinding was not feasible owing to the nature of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with IBD, scheduled for endoscopic colorectal cancer surveillance following the ECCO guidelines.
- ≥ 18 years-old.
- At least 8 year duration ulcerative colitis (UC) or colonic Crohn's disease (CD) unless in case of concomitant primary sclerosing cholangitis which any disease duration was eligible for screening colonoscopy.
Key exclusion criteria (2 listed)
- Inadequate bowel preparation (Boston Bowel Preparation Scale < 6).
- The presence of any degree of endoscopic inflammation or technical reasons that prevented completion of colonoscopy, such as a critical stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)Also: Narrow Band Imaging (NBI)Each participant was examined by two endoscopists with expertise in endoscopic surveillance in IBD on the same day consecutively in a randomized manner. Both endoscopists alternated between AI and NBI. Endoscopist 1 evaluated the entire colon using either AI -ENDO-AID CADe System (Olympus, Tokyo, Japan)- or NBI. Before lesion assessment, Endoscopist 1 first confirmed endoscopic remission, defined as a Mayo endoscopic score and a Simple Endoscopic Score for Crohn's Disease (SES-CD) for UC and CD, respectively, of 0. Then, lesions were documented and managed accordingly - resection or biopsy. Endoscopist 2, blinded to the previous findings, re-examined the entire colon with the alternate method, documented additional findings, and treated any lesions missed by Endoscopist 1. Both endoscopists performed the same number of explorations with NBI and AI as first or second exploration. High-definition endoscopes and the same processor were used for all procedures (Olympus CF-- HQ19). | Device | AI first followed by NBI, NBI first followed by AI |
Primary outcome
Neoplasia miss rate (NMR) assessed in a per-lesion analysis
Time frame: Periprocedural.
Calculated as the number of neoplastic lesions missed during the first examination and detected on the second examination, divided by the total number of neoplastic lesions detected across both examinations.
7 secondary outcomes
Neoplasia miss rate (NMR) evaluated in a per-patient analysis
Time frame: Periprocedural.
Withdrawal time
Time frame: Periprocedural.
Degree of histological inflammatory activity
Time frame: Periprocedural.
Rate of colorectal neoplasia detection
Time frame: Periprocedural.
Size of detected neoplastic lesions, by detection technique
Time frame: Periprocedural.
Morphological classification of detected neoplastic lesions, by detection technique
Time frame: Periprocedural.
Histological classification of detected neoplastic lesions, by detection technique
Time frame: Periprocedural.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 16948808Simmons DT, Harewood GC, Baron TH, Petersen BT, Wang KK, Boyd-Enders F, Ott BJ. Impact of endoscopist withdrawal speed on polyp yield: implications for optimal colonoscopy withdrawal time. Aliment Pharmacol Ther. 2006 Sep 15;24(6):965-71. doi: 10.1111/j.1365-2036.2006.03080.x.
- Background: PubMed 17167136Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
- Background: PubMed 12094842Rex DK, Bond JH, Winawer S, Levin TR, Burt RW, Johnson DA, Kirk LM, Litlin S, Lieberman DA, Waye JD, Church J, Marshall JB, Riddell RH; U.S. Multi-Society Task Force on Colorectal Cancer. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002 Jun;97(6):1296-308. doi: 10.1111/j.1572-0241.2002.05812.x. No abstract available.
- Background: PubMed 23918622van den Broek FJ, Kuiper T, Dekker E, Zwinderman AH, Fockens P, Reitsma JB. Study designs to compare new colonoscopic techniques: clinical considerations, data analysis, and sample size calculations. Endoscopy. 2013 Nov;45(11):922-7. doi: 10.1055/s-0033-1344434. Epub 2013 Aug 5.
- Background: PubMed 39819862Te Groen M, Wijnands AM, den Broeder N, de Jong DJ, van Dop WA, Duijvestein M, Fidder HH, van Schaik F, Hirdes MMC, van der Meulen-de Jong AE, Maljaars PWJ, Voorneveld PW, de Boer KHN, Peters CP, Oldenburg B, Hoentjen F; Dutch Initiative on Crohn and Colitis. Surveillance in inflammatory bowel disease: white light endoscopy with segmental re-inspection versus dye-based chromoendoscopy - a multi-arm randomised controlled trial (HELIOS). Gut. 2025 Mar 6;74(4):547-556. doi: 10.1136/gutjnl-2024-333446.
- Background: PubMed 39675405Sinopoulou V, Nigam GB, Gordon M, Ganeshan M, Tokonyai MR, Dolwani S, Iacucci M, Rutter M, Subramanian V, Wilson A, East JE; British Society of Gastroenterology Colorectal IBD Surveillance Guideline Development Group. Comparative Efficacy and Safety of Endoscopic Modalities for Colorectal Cancer Screening in Inflammatory Bowel Disease: A Systematic Review and Network Meta-analysis. Clin Gastroenterol Hepatol. 2025 Nov;23(12):2128-2143. doi: 10.1016/j.cgh.2024.11.008. Epub 2024 Dec 13.
- Background: PubMed 39303733Hassan C, Rizkala T, Mori Y, Spadaccini M, Misawa M, Antonelli G, Rondonotti E, Dekker E, Houwen BBSL, Pech O, Baumer S, Li JW, von Renteln D, Haumesser C, Maselli R, Facciorusso A, Correale L, Menini M, Schiliro A, Khalaf K, Patel H, Radadiya DK, Bhandari P, Kudo SE, Sultan S, Vandvik PO, Sharma P, Rex DK, Foroutan F, Repici A; CADx analysis study group. Computer-aided diagnosis for the resect-and-discard strategy for colorectal polyps: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):1010-1019. doi: 10.1016/S2468-1253(24)00222-X. Epub 2024 Sep 17.
- Background: PubMed 38395438Abdelrahim M, Siggens K, Iwadate Y, Maeda N, Htet H, Bhandari P. New AI model for neoplasia detection and characterisation in inflammatory bowel disease. Gut. 2024 Apr 5;73(5):725-728. doi: 10.1136/gutjnl-2023-330718. No abstract available.
- Background: PubMed 26408903Deepak P, Hanson GJ, Fletcher JG, Tremaine WJ, Pardi DS, Kisiel JB, Schroeder KW, Wong Kee Song LM, Harmsen WS, Loftus EV Jr, Bruining DH. Incremental diagnostic yield of chromoendoscopy and outcomes in inflammatory bowel disease patients with a history of colorectal dysplasia on white-light endoscopy. Gastrointest Endosc. 2016 May;83(5):1005-12. doi: 10.1016/j.gie.2015.09.021. Epub 2015 Sep 25.
- Background: PubMed 28126349Leong RW, Ooi M, Corte C, Yau Y, Kermeen M, Katelaris PH, McDonald C, Ngu M. Full-Spectrum Endoscopy Improves Surveillance for Dysplasia in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 May;152(6):1337-1344.e3. doi: 10.1053/j.gastro.2017.01.008. Epub 2017 Jan 23.
- Background: PubMed 18844620Marion JF, Waye JD, Present DH, Israel Y, Bodian C, Harpaz N, Chapman M, Itzkowitz S, Steinlauf AF, Abreu MT, Ullman TA, Aisenberg J, Mayer L; Chromoendoscopy Study Group at Mount Sinai School of Medicine. Chromoendoscopy-targeted biopsies are superior to standard colonoscopic surveillance for detecting dysplasia in inflammatory bowel disease patients: a prospective endoscopic trial. Am J Gastroenterol. 2008 Sep;103(9):2342-9. doi: 10.1111/j.1572-0241.2008.01934.x.
- Background: PubMed 23899540Efthymiou M, Allen PB, Taylor AC, Desmond PV, Jayasakera C, De Cruz P, Kamm MA. Chromoendoscopy versus narrow band imaging for colonic surveillance in inflammatory bowel disease. Inflamm Bowel Dis. 2013 Sep;19(10):2132-8. doi: 10.1097/MIB.0b013e31829637b9.
- URL to investigational product.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data underlying this article will be shared on reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Borruel, MD, PhD study chair
Vall d'Hebron University Hospital, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device) in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Ulcerative Colitis (UC), run by Vall d'Hebron Institute Research at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neoplasia miss rate (NMR) assessed in a per-lesion analysis (time frame: Periprocedural.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694362, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.