Inflammatory Bowel DiseasesOPTIC-IBDNCT04924543
OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD
A study testing Online self-learning training module and Refresher training in people with Inflammatory Bowel Diseases and Dysplasia Colon, run by University of Birmingham at 5 sites in 3 countries.
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"). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Dysplasia Colon, Dysplasia, Crohn Disease-Associated
- What is being tested?
- Online self-learning training module and Refresher training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 7 Jul 2021to 30 Apr 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Unable to give informed consent to participate in study
- Unwilling to give informed consent to participate in study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
University Aldo Moro
Bari
University of Milan
Milan
University Federico II
Naples
About this study
Official title: OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Dysplasia Colon, Dysplasia, Crohn Disease-Associated, Polyp of Colon, Ulcerative Colitis, Crohn Colitis
- Being tested
- Online self-learning training module, Refresher training
- Keywords
- Endoscopy, Optical diagnosis, Dysplasia surveillance, Inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colonic Polyps, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-learning training moduleOther
Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Refresher trainingOther
Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Online self-learning training module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 2 weeks and 8-12 weeks
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
Measured: 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
Confidence in overall optical prediction of final histopathological diagnosis
Measured: 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
Confidence in overall optical prediction of final histopathological diagnosis
Measured: 2 weeks and 8-12 weeks
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)
Measured: Baseline assessment
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)
Measured: Early post-training assessment at 2 weeks
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)
Measured: Late post-training assessment by 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start7 Jul 2021
- Primary completion20 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Milan, Federico II University, University of Bari Aldo Moro
- Responsible party
- Sponsor
- Investigators
- Marietta Iacucci, MD PhD, Study director, University of BirminghamJose G Ferraz, MD PhD, Principal investigator, University of CalgaryGian E Tontini, MD PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924543
- Sponsor's protocol ID
- ERN-18-0222A
- Other IDs
- REB21-0409
- Acronym
- OPTIC-IBD
- Status last verified
- May 2022
- First submitted
- 7 Jun 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD as not applicable to this study
Publications
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.
PubMed 31435169Bye 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.
PubMed 30353058Gabbani 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.
PubMed 25789093Iacucci 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.
PubMed 30541154Cassinotti 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.
PubMed 33015345Mazzuoli 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.
PubMed 23932331Vuitton 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.
PubMed 28112419van 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.
PubMed 33094654Iacucci 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.
PubMed 28322774Ibraheim 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.
PubMed 30245789Allen 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.
PubMed 28945617Khan 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.
PubMed 28806820Smith 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.
PubMed 30844114Iacucci 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.
PubMed 37993058
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04924543
- Acronym / sponsor ID
- OPTIC-IBD / ERN-18-0222A
- Conditions
- Inflammatory Bowel Diseases, Dysplasia Colon, Dysplasia, Crohn Disease-Associated, Polyp of Colon, Ulcerative Colitis, Crohn Colitis
- Keywords
- Endoscopy, Optical diagnosis, Dysplasia surveillance, Inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of Calgary, University of Milan, Federico II University, University of Bari Aldo Moro
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 14 Jun 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Received short refresher training on optical diagnosis | Active comparator | Other: Online self-learning training module, Other: Refresher trainingAll 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 |
| No refresher training | Active comparator | Other: Online self-learning training moduleAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Unable to give informed consent to participate in study
- Unwilling to give informed consent to participate in study
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 |
|---|---|---|
| Online self-learning training moduleTraining module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy | Other | No refresher training, Received short refresher training on optical diagnosis |
| Refresher trainingBrief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy | Other | Received short refresher training on optical diagnosis |
Primary outcome
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module
Time frame: Baseline and 2 weeks
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
8 secondary outcomes
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
Time frame: 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
Time frame: 2 weeks and 8-12 weeks
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module
Time frame: 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
Time frame: 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
Time frame: 2 weeks and 8-12 weeks
Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module
Time frame: Baseline assessment
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
Time frame: Early post-training assessment at 2 weeks
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
Time frame: Late post-training assessment by 8-12 weeks
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 18 May 2022.
- Background: PubMed 31435169Clarke 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.
- Background: PubMed 30353058Bye 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.
- Background: PubMed 25789093Gabbani 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.
- Background: PubMed 30541154Iacucci 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.
- Background: PubMed 33015345Cassinotti 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.
- Background: PubMed 23932331Mazzuoli 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.
- Background: PubMed 28112419Vuitton 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.
- Background: PubMed 33094654van 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.
- Background: PubMed 28322774Iacucci 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.
- Background: PubMed 30245789Ibraheim 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.
- Background: PubMed 28945617Allen 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.
- Background: PubMed 28806820Khan 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.
- Individual participant dataSharing planned: No. No plan to share IPD as not applicable to this study
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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.
Marietta Iacucci, MD PhD study director
University of Birmingham
Jose G Ferraz, MD PhD principal investigator
University of Calgary
Gian E Tontini, MD PhD principal investigator
University of Milan
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online self-learning training module and Refresher training in people with Inflammatory Bowel Diseases and Dysplasia Colon, run by University of Birmingham at 5 sites in 3 countries.
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 4 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Canada, United Kingdom. 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?
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module (time frame: Baseline and 2 weeks). 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 NCT04924543, which also lists 14 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 18 May 2022.