Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease

NCT07694362 | Completed DMC

• 1 other identifier: CLEAR-IBD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Ulcerative Colitis (UC); Crohn's Disease Colon; Colonic Dysplasia/Adenomata; Artificial Intelligence (AI); NBI; Chromoendoscopy; Surveillance Colonoscopy

Keywords

Inflammatory Bowel Disease; Narrow Band Imaging (NBI); Chromoendoscopy; Colonic Dysplasia; Surveillance; Artificial Intelligence (AI)

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural.

Secondary Outcomes (7)

• Neoplasia miss rate (NMR) evaluated in a per-patient analysis

  Periprocedural.

• Withdrawal time

  Periprocedural.

• Degree of histological inflammatory activity

  Periprocedural.

• Rate of colorectal neoplasia detection

  Periprocedural.

• Size of detected neoplastic lesions, by detection technique

  Periprocedural.

Study Arms (2)

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.

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.

Device: ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device)

Interventions

ENDO-AID CADe System (Olympus, Tokyo, Japan) (AI device) DEVICE

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).

Also known as: Narrow Band Imaging (NBI)

AI first followed by NBI; NBI first followed by AI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vall d'Hebron Institute Research: lead
• Societat Catalana de Digestologia: collaborator

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (30)

• 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.

  PMID: 16948808 BACKGROUND

• Barclay 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.

  PMID: 17167136 BACKGROUND

• Rex 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.

  PMID: 12094842 BACKGROUND

• van 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.

  PMID: 23918622 BACKGROUND

• Te 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.

  PMID: 39819862 BACKGROUND

• Sinopoulou 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.

  PMID: 39675405 BACKGROUND

• Hassan 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.

  PMID: 39303733 BACKGROUND

• Abdelrahim 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.

  PMID: 38395438 BACKGROUND

• Deepak 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.

  PMID: 26408903 BACKGROUND

• Leong 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.

  PMID: 28126349 BACKGROUND

• Marion 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.

  PMID: 18844620 BACKGROUND

• Efthymiou 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.

  PMID: 23899540 BACKGROUND

• Lopez-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.

  PMID: 38740327 BACKGROUND

• Rajpurkar 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.

  PMID: 37224199 BACKGROUND

• Yamamoto 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.

  PMID: 35644932 BACKGROUND

• Liu X, Reigle J, Prasath VBS, Dhaliwal J. Artificial intelligence image-based prediction models in IBD exhibit high risk of bias: A systematic review. Comput Biol Med. 2024 Mar;171:108093. doi: 10.1016/j.compbiomed.2024.108093. Epub 2024 Feb 1.

  PMID: 38354499 BACKGROUND

• Samarasena J, Yang D, Berzin TM. AGA Clinical Practice Update on the Role of Artificial Intelligence in Colon Polyp Diagnosis and Management: Commentary. Gastroenterology. 2023 Dec;165(6):1568-1573. doi: 10.1053/j.gastro.2023.07.010. Epub 2023 Oct 17.

  PMID: 37855759 BACKGROUND

• Wallace MB, Sharma P, Bhandari P, East J, Antonelli G, Lorenzetti R, Vieth M, Speranza I, Spadaccini M, Desai M, Lukens FJ, Babameto G, Batista D, Singh D, Palmer W, Ramirez F, Palmer R, Lunsford T, Ruff K, Bird-Liebermann E, Ciofoaia V, Arndtz S, Cangemi D, Puddick K, Derfus G, Johal AS, Barawi M, Longo L, Moro L, Repici A, Hassan C. Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007. Epub 2022 Mar 15.

  PMID: 35304117 BACKGROUND

• Piccioni RG, Mauzerall DC. Calcium and photosynthetic oxygen evolution in cyanobacteria. Biochim Biophys Acta. 1978 Dec 7;504(3):384-97. doi: 10.1016/0005-2728(78)90061-0.

  PMID: 102341 BACKGROUND

• Lee MCM, Parker CH, Liu LWC, Farahvash A, Jeyalingam T. Impact of study design on adenoma detection in the evaluation of artificial intelligence-aided colonoscopy: a systematic review and meta-analysis. Gastrointest Endosc. 2024 May;99(5):676-687.e16. doi: 10.1016/j.gie.2024.01.021. Epub 2024 Jan 24.

  PMID: 38272274 BACKGROUND

• Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019 Mar;114(3):384-413. doi: 10.14309/ajg.0000000000000152.

  PMID: 30840605 BACKGROUND

• Murthy SK, Feuerstein JD, Nguyen GC, Velayos FS. AGA Clinical Practice Update on Endoscopic Surveillance and Management of Colorectal Dysplasia in Inflammatory Bowel Diseases: Expert Review. Gastroenterology. 2021 Sep;161(3):1043-1051.e4. doi: 10.1053/j.gastro.2021.05.063.

  PMID: 34416977 BACKGROUND

• Gordon H, Biancone L, Fiorino G, Katsanos KH, Kopylov U, Al Sulais E, Axelrad JE, Balendran K, Burisch J, de Ridder L, Derikx L, Ellul P, Greuter T, Iacucci M, Di Jiang C, Kapizioni C, Karmiris K, Kirchgesner J, Laharie D, Lobaton T, Molnar T, Noor NM, Rao R, Saibeni S, Scharl M, Vavricka SR, Raine T. ECCO Guidelines on Inflammatory Bowel Disease and Malignancies. J Crohns Colitis. 2023 Jun 16;17(6):827-854. doi: 10.1093/ecco-jcc/jjac187. No abstract available.

  PMID: 36528797 BACKGROUND

• Gallinger ZR, Rumman A, Murthy SK, Nguyen GC. Perspectives on endoscopic surveillance of dysplasia in inflammatory bowel disease: a survey of academic gastroenterologists. Endosc Int Open. 2017 Oct;5(10):E974-E979. doi: 10.1055/s-0043-117944. Epub 2017 Oct 4.

  PMID: 28983504 BACKGROUND

• Gordon C, Chee D, Hamilton B, Heerasing NM, Hendy P, Chanchlani N, Lin S, Wesley E, Daniels IR, Silva N, Osborne M, Kennedy NA, Goodhand JR, Ahmad T. Root-cause analyses of missed opportunities for the diagnosis of colorectal cancer in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2021 Jan;53(2):291-301. doi: 10.1111/apt.16155. Epub 2020 Nov 7.

  PMID: 33159472 BACKGROUND

• East JE, Gordon M, Nigam GB, Sinopoulou V, Bateman AC, Din S, Iacucci M, Kabir M, Lamb CA, Wilson A, Al Bakir I, Dhar A, Dolwani S, Faiz O, Hart A, Hayee B, Healey C, Leedham SJ, Novelli MR, Raine T, Rutter MD, Shepherd NA, Subramanian V, Vance M, Wakeman R, White L, Trudgill NJ, Morris AJ. British Society of Gastroenterology guidelines on colorectal surveillance in inflammatory bowel disease. Gut. 2025 Apr 30;75(3):e335023. doi: 10.1136/gutjnl-2025-335023. Online ahead of print.

  PMID: 40306978 BACKGROUND

• Bye WA, Ma C, Nguyen TM, Parker CE, Jairath V, East JE. Strategies for Detecting Colorectal Cancer in Patients with Inflammatory Bowel Disease: A Cochrane Systematic Review and Meta-Analysis. Am J Gastroenterol. 2018 Dec;113(12):1801-1809. doi: 10.1038/s41395-018-0354-7. Epub 2018 Oct 23.

  PMID: 30353058 BACKGROUND

• Wan Q, Zhao R, Xia L, Wu Y, Zhou Y, Wang Y, Cui Y, Shen X, Wu XT. Inflammatory bowel disease and risk of gastric, small bowel and colorectal cancer: a meta-analysis of 26 observational studies. J Cancer Res Clin Oncol. 2021 Apr;147(4):1077-1087. doi: 10.1007/s00432-020-03496-0. Epub 2021 Jan 12.

  PMID: 33433655 BACKGROUND

• Olen O, Erichsen R, Sachs MC, Pedersen L, Halfvarson J, Askling J, Ekbom A, Sorensen HT, Ludvigsson JF. Colorectal cancer in Crohn's disease: a Scandinavian population-based cohort study. Lancet Gastroenterol Hepatol. 2020 May;5(5):475-484. doi: 10.1016/S2468-1253(20)30005-4. Epub 2020 Feb 14.

  PMID: 32066530 BACKGROUND

• Olen O, Erichsen R, Sachs MC, Pedersen L, Halfvarson J, Askling J, Ekbom A, Sorensen HT, Ludvigsson JF. Colorectal cancer in ulcerative colitis: a Scandinavian population-based cohort study. Lancet. 2020 Jan 11;395(10218):123-131. doi: 10.1016/S0140-6736(19)32545-0.

  PMID: 31929014 BACKGROUND

Related Links

• URL to investigational product.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Natalia Borruel, MD, PhD

  Vall d'Hebron University Hospital, Barcelona, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 9, 2026
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon reasonable request.
• Access Criteria: Upon reasonable request.

Locations

ES (1)