OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

NCT04924543 | Completed

• 2 other identifiers: ERN-18-0222AREB21-0409
• Study Type: interventional
• Target: 182
• Locations: 3 countries
• Sites: 5

Brief Summary

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs. This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

Conditions

Inflammatory Bowel Diseases; Dysplasia Colon; Dysplasia, Crohn Disease-Associated; Polyp of Colon; Ulcerative Colitis; Crohn Colitis; Crohn Disease

Keywords

Endoscopy; Optical diagnosis; Dysplasia surveillance; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module

  Accuracy in characterization by modified SCENIC classification \[Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations\], modified Kudo pit pattern classification, FACILE classification \[Frankfurt Advanced Chromoendoscopic Inflammatory Bowel Disease Lesions\], optical prediction of final histopathological diagnosis

  Baseline and 2 weeks

Secondary Outcomes (8)

• Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module, impact of short refresher training

  Baseline and 8-12 weeks

• Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - retention between participants randomized to receive or not receive refresher training

  2 weeks and 8-12 weeks

• Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module

  Baseline and 2 weeks

• Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher training

  Baseline and 8-12 weeks

• Change in participant assessment of confidence of prediction for each video (High vs. Low) - at re-assessment between participants randomized to receive or not receive short refresher training

  2 weeks and 8-12 weeks

Other Outcomes (5)

• Quality of training module

  Baseline assessment

• Quality of training module

  Early post-training assessment by 2 weeks

• Quality of training module

  Late post-training assessment by 8-12 weeks

Study Arms (2)

Received short refresher training on optical diagnosis

ACTIVE COMPARATOR

All participants receive access to the training module, with assessments at baseline, week 2 and week 8-12 Half of participants randomized 1:1 will also receive access to brief refresher training by week 8

Other: Online self-learning training module; Other: Refresher training

No refresher training

ACTIVE COMPARATOR

All participants receive access to the training module, with assessments at baseline, week 2 and week 8-12 This arm does not also receive access to brief refresher training

Other: Online self-learning training module

Interventions

Online self-learning training module OTHER

Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

No refresher training; Received short refresher training on optical diagnosis

Refresher training OTHER

Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Received short refresher training on optical diagnosis

Eligibility Criteria

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

You may qualify if:

• Specialist physicians performing gastrointestinal endoscopy
• Non-medical endoscopists
• Endoscopists in training with various levels of experience (such as Specialty Registrar, Fellow, Resident, non-medical endoscopists in training)
• Novice endoscopists with no or limited experience (no previous exposure bias to endoscopy training or practice)

You may not qualify if:

• Unable to give informed consent to participate in study
• Unwilling to give informed consent to participate in study

Sponsors & Collaborators

• University of Birmingham: lead
• University of Calgary: collaborator
• University of Milan: collaborator
• Federico II University: collaborator
• University of Bari Aldo Moro: collaborator

Study Sites (5)

University of Calgary

Calgary, Alberta, Canada

Location

University Aldo Moro

Bari, Italy

Location

University of Milan

Milan, Italy

Location

University Federico II

Napoli, Italy

Location

University of Birmingham

Birmingham, United Kingdom

Location

Related Publications (14)

• Clarke WT, Feuerstein JD. Colorectal cancer surveillance in inflammatory bowel disease: Practice guidelines and recent developments. World J Gastroenterol. 2019 Aug 14;25(30):4148-4157. doi: 10.3748/wjg.v25.i30.4148.

  PMID: 31435169 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

• Gabbani T, Manetti N, Bonanomi AG, Annese AL, Annese V. New endoscopic imaging techniques in surveillance of inflammatory bowel disease. World J Gastrointest Endosc. 2015 Mar 16;7(3):230-6. doi: 10.4253/wjge.v7.i3.230.

  PMID: 25789093 BACKGROUND

• Iacucci M, McQuaid K, Gui XS, Iwao Y, Lethebe BC, Lowerison M, Matsumoto T, Shivaji UN, Smith SCL, Subramanian V, Uraoka T, Sanduleanu S, Ghosh S, Kiesslich R. A multimodal (FACILE) classification for optical diagnosis of inflammatory bowel disease associated neoplasia. Endoscopy. 2019 Feb;51(2):133-141. doi: 10.1055/a-0757-7759. Epub 2018 Dec 12.

  PMID: 30541154 BACKGROUND

• Cassinotti A, Fociani P, Duca P, Nebuloni M, Davies SEC, Sampietro G, Buffoli F, Corona A, Maconi G, Ardizzone S. Modified Kudo classification can improve accuracy of virtual chromoendoscopy with FICE in endoscopic surveillance of ulcerative colitis. Endosc Int Open. 2020 Oct;8(10):E1414-E1422. doi: 10.1055/a-1165-0169. Epub 2020 Sep 22.

  PMID: 33015345 BACKGROUND

• Mazzuoli S, Guglielmi FW, Antonelli E, Salemme M, Bassotti G, Villanacci V. Definition and evaluation of mucosal healing in clinical practice. Dig Liver Dis. 2013 Dec;45(12):969-77. doi: 10.1016/j.dld.2013.06.010. Epub 2013 Aug 7.

  PMID: 23932331 BACKGROUND

• Vuitton L, Peyrin-Biroulet L, Colombel JF, Pariente B, Pineton de Chambrun G, Walsh AJ, Panes J, Travis SP, Mary JY, Marteau P. Defining endoscopic response and remission in ulcerative colitis clinical trials: an international consensus. Aliment Pharmacol Ther. 2017 Mar;45(6):801-813. doi: 10.1111/apt.13948. Epub 2017 Jan 23.

  PMID: 28112419 BACKGROUND

• van der Laan JJH, van der Waaij AM, Gabriels RY, Festen EAM, Dijkstra G, Nagengast WB. Endoscopic imaging in inflammatory bowel disease: current developments and emerging strategies. Expert Rev Gastroenterol Hepatol. 2021 Feb;15(2):115-126. doi: 10.1080/17474124.2021.1840352. Epub 2020 Oct 31.

  PMID: 33094654 BACKGROUND

• Iacucci M, Daperno M, Lazarev M, Arsenascu R, Tontini GE, Akinola O, Gui XS, Villanacci V, Goetz M, Lowerison M, Lethebe BC, Vecchi M, Neumann H, Ghosh S, Bisschops R, Kiesslich R. Development and reliability of the new endoscopic virtual chromoendoscopy score: the PICaSSO (Paddington International Virtual ChromoendoScopy ScOre) in ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1118-1127.e5. doi: 10.1016/j.gie.2017.03.012. Epub 2017 Mar 18.

  PMID: 28322774 BACKGROUND

• Ibraheim H, Dhillon AS, Koumoutsos I, Gulati S, Hayee B. Curriculum review: colorectal cancer surveillance and management of dysplasia in IBD. Frontline Gastroenterol. 2018 Oct;9(4):271-277. doi: 10.1136/flgastro-2017-100919. Epub 2018 Feb 10.

  PMID: 30245789 BACKGROUND

• Allen JE, Vennalaganti P, Gupta N, Hornung B, Choudhary A, Titi M, Alsop BR, Lim D, Sharma P. Randomized Controlled Trial of Self-directed Versus In-Classroom Education of Narrow Band Imaging in Diagnosing Colorectal Polyps Using the NICE Criteria. J Clin Gastroenterol. 2018 May/Jun;52(5):413-417. doi: 10.1097/MCG.0000000000000791.

  PMID: 28945617 BACKGROUND

• Khan T, Cinnor B, Gupta N, Hosford L, Bansal A, Olyaee MS, Wani S, Rastogi A. Didactic training vs. computer-based self-learning in the prediction of diminutive colon polyp histology by trainees: a randomized controlled study. Endoscopy. 2017 Dec;49(12):1243-1250. doi: 10.1055/s-0043-116015. Epub 2017 Aug 14.

  PMID: 28806820 BACKGROUND

• Smith SCL, Saltzman J, Shivaji UN, Lethebe BC, Cannatelli R; Birmingham Colonic Polyp Characterisation Group; Ghosh S, Iacucci M. Randomized controlled study of the prediction of diminutive/small colorectal polyp histology using didactic versus computer-based self-learning module in gastroenterology trainees. Dig Endosc. 2019 Sep;31(5):535-543. doi: 10.1111/den.13389. Epub 2019 Apr 8.

  PMID: 30844114 BACKGROUND

• Iacucci M, Bonovas S, Bazarova A, Cannatelli R, Ingram RJM, Labarile N, Nardone OM, Parigi TL, Piovani D, Siau K, Smith SCL, Zammarchi I, Ferraz JGP, Fiorino G, Kiesslich R, Panaccione R, Parra-Blanco A, Principi M, Tontini GE, Uraoka T, Ghosh S; OPTIC-IBD Study Group. Validation of a new optical diagnosis training module to improve dysplasia characterization in inflammatory bowel disease: a multicenter international study. Gastrointest Endosc. 2024 May;99(5):756-766.e4. doi: 10.1016/j.gie.2023.11.018. Epub 2023 Nov 21.

  PMID: 37993058 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colonic Polyps; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Study Officials

• Marietta Iacucci, MD PhD

  University of Birmingham

  STUDY DIRECTOR

• Jose G Ferraz, MD PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Gian E Tontini, MD PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking planned
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants are allocated to the same intervention, with pre-course and post-course assessments. Participants will then be randomized 1:1 to one of two arms: (1) to receive short refresher training on optical diagnosis, or (2) no additional intervention. All participants will complete a final late post-course assessment to test knowledge retention from the training module and the impact of refresher training.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: July 7, 2021
• Primary Completion: December 20, 2021
• Study Completion: April 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (1); IT (3)