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OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04924543
Acronym
OPTIC-IBD
Enrollment
182
Registered
2021-06-14
Start date
2021-07-07
Completion date
2022-04-30
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Endoscopy, Optical diagnosis, Dysplasia surveillance, Inflammatory bowel disease

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.

Detailed 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.

Interventions

OTHEROnline self-learning training module

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

OTHERRefresher training

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

Sponsors

University of Calgary
CollaboratorOTHER
University of Milan
CollaboratorOTHER
Federico II University
CollaboratorOTHER
University of Bari Aldo Moro
CollaboratorOTHER
University of Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Masking description

No masking planned

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training moduleBaseline and 2 weeksAccuracy 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

Secondary

MeasureTime frameDescription
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 trainingBaseline and 8-12 weeksAccuracy 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
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 training2 weeks and 8-12 weeksAccuracy 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
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training moduleBaseline and 2 weeksConfidence in overall optical prediction of final histopathological diagnosis
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher trainingBaseline and 8-12 weeksConfidence in overall optical prediction of final histopathological diagnosis
Participant assessment of impact of training module on overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training moduleEarly post-training assessment at 2 weeksConfidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
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 trainingLate post-training assessment by 8-12 weeksConfidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
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 training2 weeks and 8-12 weeksConfidence in overall optical prediction of final histopathological diagnosis
Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training moduleBaseline assessmentConfidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)

Other

MeasureTime frameDescription
Quality of training moduleBaseline assessmentParticipant assessment of quality of each video (High vs. Low)
Quality of brief refresher trainingAt provision of brief refresher training by 8 weeksModule 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?

Countries

Canada, Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026