OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

Ulcerative Colitis Clinical Trial

— OPTIC-IBD  

Official title:

OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924543
• Other study ID #: ERN-18-0222A
• Secondary ID: REB21-0409
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterise dysplasia in inflammatory bowel disease (IBD), to ultimately improve decision-making, reporting of dysplastic lesions and management during IBD surveillance.

Colonoscopy (endoscopic examination of the lower bowel) is a well-established screening tool to identify lesions within the bowel and objectively assess the degree of inflammation present. Patients with IBD, both Ulcerative colitis (UC) and Crohn's disease (CD), have a higher risk of developing cancers of the bowel and it is for this reason that they undergo regular surveillance procedures. Guidelines recommend surveillance procedures using high definition white light endoscopy alongside either Dye-Based Chromoendoscopy (DCE) or Virtual Chromoendoscopy (VCE), with targeted biopsies. However, the real world adoption of DCE and VCE is still modest. Due to technological advances there are alternative endoscopic imaging techniques that selectively enhance certain mucosal and vascular features, including narrow-band imaging (NBI), i-Scan optical enhancement (i-Scan-OE) and blue laser imaging (BLI).

These technologies have been demonstrated to be more effective than standard white light endoscopy. Despite these advances in technology, detecting dysplasia within areas of inflammation due to IBD is challenging. An endoscopic classification was recently developed by Iacucci M et al called "FACILE" to characterise in detail the mucosal and vascular pattern to predict histological colonic lesions in IBD. Since traditional lesion assessment systems such as (unmodified) Kudo pit pattern are less reliable in IBD, there is a need for a robust scoring system to assist clinicians in detecting and characterising lesions in IBD.

This project is to validate a training module on surveillance and colonic lesion characterisation in IBD. We aim to compare polyp detection in IBD surveillance procedures before and after training and evaluate the impact. As a sub-study, an additional randomisation process will take place whereby one group will receive additional focused top-up training and the other group will not. We will seek to compare the impact of feedback on knowledge retention.

Study stages:

• Stage 1. Potential participants are provided an electronic PIS outlining the study.

• Stage 2. Participants consent to the study and complete the pre-training assessment on REDCap (1 hour).

• Stage 3. Participants are provided with login details for online training.

• Stage 4. Participants complete the online training in their own time (1 hour).

• Stage 5. Participants complete the same assessment (as pre-training) and are given 1-2 weeks to complete this after training.

• Sub-study: Participants are randomised 1:1 to either receive or not receive a short refresher training module (15 min).

• Stage 6. After 8-12 weeks post-training participants are invited to complete the same assessment process (as pre-training).

All participants will receive computer-based training. Training will take place via an online computer- based self-learning platform. The training will include reviewing short videos of colorectal polyps in patients with IBD and videos of inflammation in IBD (quiescent, mild, moderate and severe) using NBI, i-Scan-OE and BLI. Patients were consented for the use of the use of videos for educational purposes. Videos used have been fully anonymised.

All Participants are given access to the secure REDCap platform hosted at the University of Birmingham. Participants will be required to register using a general survey to include their email address, anonymised demographic data, procedural experience and familiarity with optical endoscopic diagnosis platforms.

Participants comprise three categories: novice, training endoscopist and experienced endoscopist. The latter two are the key categories for evaluation.

• Novice will include medical students and junior doctors/residents who have previously had no or little endoscopic experience.

• Training endoscopists will be gastroenterology and general surgery trainees/residents/fellows.

• Experienced endoscopists will be fully qualified endoscopists such as GI and general surgery staff, consultants and nurse endoscopists.

Participants will then complete pre-training assessment prior to e-learning training. There are 26 video clips representative of different types of colonic lesions in IBD. Each video clip is typically 20-30 seconds. The overall duration of the assessment is around one hour.

Participants will then be given a login for the online training material and will complete this in their own time. Participants will be taught on endoscopic surveillance in IBD and how to characterise polyps accurately. The duration of the training module is 1 hour. It is interactive with optional components for tailored self-directed learning.

A post-training assessment will be completed in the next 1-2 weeks, using the same video clips, allowing us to compare the performance of participants before and after training. The assessment will be repeated after 8-12 weeks to assess the retention of skills.

An additional randomisation process on a 1:1 basis will take place, whereby one group will receive additional short refresher training following their responses to assessment questions and the other group will not. We will seek to compare the impact of feedback on sustainability of knowledge retention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 30, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• 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)

Exclusion criteria:

• Unable to give informed consent to participate in study

• Unwilling to give informed consent to participate in study

Related Conditions & MeSH terms

• Colitis
• Colonic Polyps
• Crohn Colitis
• Crohn Disease
• Hyperplasia
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Polyp of Colon
• Ulcerative Colitis

Intervention

Other:
• Online self-learning training module
Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
• Refresher training
Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Italy	University Aldo Moro	Bari
Italy	University of Milan	Milano
Italy	University Federico II	Napoli
United Kingdom	University of Birmingham	Birmingham

Sponsors (5)

Lead Sponsor	Collaborator
University of Birmingham	Federico II University, University of Bari Aldo Moro, University of Calgary, University of Milan

Countries where clinical trial is conducted

Canada,  Italy,  United Kingdom, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

van der Laan JJH, van der Waaij AM, Gabriëls 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. Review. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of training module	Participant assessment of quality of each video (High vs. Low)	Baseline assessment
Other	Quality of training module	Participant assessment of quality of each video (High vs. Low)	Early post-training assessment by 2 weeks
Other	Quality of training module	Participant assessment of quality of each video (High vs. Low)	Late post-training assessment by 8-12 weeks
Other	Quality of training module	Module evaluation by Likert scales (strongly agree, agree, neither agree or disagree, disagree, strongly disagree) for "The module has been effective in helping me to learn" and "The module content was relevant" and "The module length was appropriate" and "I would recommend the module" and "The assessments matched the module content", and evaluation by free text comments "What have you learned in this module that will impact on your clinical practice?" and "Describe the best and worst thing about this module" and "How would you change or improve this module?"	At provision of training module by 2 weeks
Other	Quality of brief refresher training	Module evaluation by Likert scales (strongly agree, agree, neither agree or disagree, disagree, strongly disagree) for "The refresher training has been effective in helping me to consolidate my learning" and "The refresher training content was relevant" and "The refresher training length was appropriate" and "I would recommend including refresher training in the program", and evaluation by free text comments "Describe the best and worst thing about this refresher training" and "How would you change or improve this refresher training?"	At provision of brief refresher training by 8 weeks
Primary	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	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	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], overall optical prediction of final histopathological diagnosis	Baseline and 8-12 weeks
Secondary	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	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], overall optical prediction of final histopathological diagnosis	2 weeks and 8-12 weeks
Secondary	Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module	Confidence in overall optical prediction of final histopathological diagnosis	Baseline and 2 weeks
Secondary	Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher training	Confidence in overall optical prediction of final histopathological diagnosis	Baseline and 8-12 weeks
Secondary	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	Confidence in overall optical prediction of final histopathological diagnosis	2 weeks and 8-12 weeks
Secondary	Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module	Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)	Baseline assessment
Secondary	Participant assessment of impact of training module on overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module	Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)	Early post-training assessment at 2 weeks
Secondary	Participant assessment of impact of training program on overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module with or without brief refresher training	Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)	Late post-training assessment by 8-12 weeks

External Links

•   OPTIC-IBD