IBD (Inflammatory Bowel Disease)CONCORDIANCT06961942
Enhancing Endoscopic Scoring Consistency and Accuracy in IBD: a Video-based Training Approach
A study testing Training in people with IBD (Inflammatory Bowel Disease), run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gastroenterology fellows
Who cannot join
- NA
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Read more
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems.
The primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.
Read the detailed description
Endoscopy is a cornerstone in diagnosis, management and monitoring of patients with inflammatory bowel disease (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC). Endoscopy in combination with histological assessment plays a crucial role in diagnosis of IBD, distinguishing between UC and CD and ruling out other diseases with similar clinical presentations. The STRIDE-II consensus, developed by the International Organization for the Study of IBD (IOIBD), highlights endoscopic healing as the primary long-term therapeutic goal. Achieving endoscopic healing is associated with improved patient outcomes, including steroid-free remission, a reduced risk of clinical relapse, hospitalization, colectomy, and dysplasia or colorectal cancer.
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
The most widely adapted scoring systems in IBD include:
- The Simple Endoscopic Score for Crohn's Disease (SES-CD) evaluates four key parameters: ulcer size, ulcerated surface, affected surface area, and luminal narrowing. It offers a straightforward, clinically validated scoring system that strongly correlates with indices such as the Crohn's Disease Activity Index.
- The updated Rutgeerts Score provides accurate and clinically relevant assessments of postoperative recurrence in CD and facilitates the prediction of clinical and surgical outcomes for patients with an ileocolonic anastomosis.
- The Endoscopic Mayo Score is a component of the broader Mayo scoring system used to assess disease activity in UC. It evaluates the extent and severity of mucosal inflammation, correlating well with clinical outcomes, including treatment response.
- The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) standardizes the evaluation of endoscopic severity in UC. It incorporates more detailed descriptors of mucosal appearance, including vascular pattern, bleeding, erosions, and ulcerations to describe overall disease severity (Neurath \& Travis, 2012).
- The Pouchitis Disease Activity Index (PDAI) assesses pouchitis severity using clinical symptoms, endoscopic findings, and histological features of the pouch. This quantitative tool helps to diagnose and monitor pouchitis. Endoscopic part of PDAI (ePDAI) consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration.
- The Simplified Endoscopic Score for Pouchitis (SES-pouchitis), recently suggested as an alternative to the PDAI, adapts the SES-CD framework to focus on one single segment, namely the ileal pouch.
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems. Daperno et al. demonstrated in their study that a structured educational training program significantly enhanced inter-observer agreement. The study, including 237 gastroenterologists with at least three years of post-certification experience, showed substantial improvements in scoring consistency across multiple IBD scoring systems (SES-CD, Mayo Endoscopic Subscore, and Rutgeerts Score) following the training. These findings emphasize the importance of comprehensive training to ensure reliable and consistent endoscopic evaluations. Intensive education programs are crucial for improving scoring accuracy, enabling effective disease monitoring and management in IBD.
New scoring systems for assessing disease activity are developing, however, they are relatively unknown among gastroenterologists and are not yet widely used in clinical practice.
In the CONCORDIA study, the investigators will evaluate gastroenterology fellows' familiarity with these new scoring systems and assess whether structured endoscopic video assisted training improves scoring accuracy.
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Training
- Keywords
- Training, Scoring, IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
A structured teaching module for fellows in training will be prepared and conducted at three university centres, namely University Hospitals Leuven, Ljubljana University Medical Centre, and CHU de Bordeaux. The training module will include short endoscopic videos (different from the pre- and post-training set), which participants will score in real-time using a polling application. This will be followed by a step-by-step demonstration of each scoring principle with explanations of the reasoning behind specific scores. Each scoring system will be reviewed in a short training video that provides a structured demonstration, highlights common pitfalls, and showcases typical IBD-associated endoscopic features. After the video training, participants will have the opportunity to ask questions to the experts.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Early training) | Active comparator | Following the first video assessment only participants in Group A will attend the structured training module.
During Time Period 2 (approximately one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. Receives: Other: Training |
| Group B (Late training) | No intervention | After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (approximately one month), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training module. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos
In substudy A, the investigators will focus on the updated Rutgeerts score for patients with Crohn's disease that previously underwent an ileocolonic resection with ileocolonic anastomosis.
Measured: 3 months
Improvement of ePDAI scoring accuracy after training with structured educational videos
In substudy B, the investigators will focus on the Endoscopic element of the Pouchitis Disease Activity Index (ePDAI) for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA).
ePDAI consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration.
Measured: 3 months
IImprovement of SES-pouchitis scoring accuracy after training with structured educational videos
In substudy B, the investigators will focus on the Simple Endoscopic Score (SES)-pouchitis for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA).
SES-pouchitis evaluates four key parameters, ulcer size, ulcerated surface, affected surface area, and luminal narrowing, in the ileal pouch.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- The CONCORDIA study will be conducted in three sequential time periods. During Time Period 1 (two months), all participants will independently score 15 endoscopic videos using the updated Rutgeerts score and 15 videos with ePDAI and SES-pouch, supplemented with a general Visual Analogue Scale (VAS) score (0=no inflammation, 10=most severe inflammation). No specific guidance will be provided during that phase. Following the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (one months), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961942
- Sponsor's protocol ID
- CONCORDIA
- Acronym
- CONCORDIA
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary objective of this study is to set-up a training for gastroenterology fellows
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Endoscopic Scoring Consistency and Accuracy in IBD: a Video-based Training Approach
- ClinicalTrials.gov ID
- NCT06961942
- Acronym / sponsor ID
- CONCORDIA / CONCORDIA
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Training, Scoring, IBD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 May 2025 (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.
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems.
The primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.
Detailed description
Endoscopy is a cornerstone in diagnosis, management and monitoring of patients with inflammatory bowel disease (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC). Endoscopy in combination with histological assessment plays a crucial role in diagnosis of IBD, distinguishing between UC and CD and ruling out other diseases with similar clinical presentations. The STRIDE-II consensus, developed by the International Organization for the Study of IBD (IOIBD), highlights endoscopic healing as the primary long-term therapeutic goal. Achieving endoscopic healing is associated with improved patient outcomes, including steroid-free remission, a reduced risk of clinical relapse, hospitalization, colectomy, and dysplasia or colorectal cancer.
Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.
The most widely adapted scoring systems in IBD include:
- The Simple Endoscopic Score for Crohn's Disease (SES-CD) evaluates four key parameters: ulcer size, ulcerated surface, affected surface area, and luminal narrowing. It offers a straightforward, clinically validated scoring system that strongly correlates with indices such as the Crohn's Disease Activity Index.
- The updated Rutgeerts Score provides accurate and clinically relevant assessments of postoperative recurrence in CD and facilitates the prediction of clinical and surgical outcomes for patients with an ileocolonic anastomosis.
- The Endoscopic Mayo Score is a component of the broader Mayo scoring system used to assess disease activity in UC. It evaluates the extent and severity of mucosal inflammation, correlating well with clinical outcomes, including treatment response.
- The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) standardizes the evaluation of endoscopic severity in UC. It incorporates more detailed descriptors of mucosal appearance, including vascular pattern, bleeding, erosions, and ulcerations to describe overall disease severity (Neurath \& Travis, 2012).
- The Pouchitis Disease Activity Index (PDAI) assesses pouchitis severity using clinical symptoms, endoscopic findings, and histological features of the pouch. This quantitative tool helps to diagnose and monitor pouchitis. Endoscopic part of PDAI (ePDAI) consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration.
- The Simplified Endoscopic Score for Pouchitis (SES-pouchitis), recently suggested as an alternative to the PDAI, adapts the SES-CD framework to focus on one single segment, namely the ileal pouch.
One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.
Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems. Daperno et al. demonstrated in their study that a structured educational training program significantly enhanced inter-observer agreement. The study, including 237 gastroenterologists with at least three years of post-certification experience, showed substantial improvements in scoring consistency across multiple IBD scoring systems (SES-CD, Mayo Endoscopic Subscore, and Rutgeerts Score) following the training. These findings emphasize the importance of comprehensive training to ensure reliable and consistent endoscopic evaluations. Intensive education programs are crucial for improving scoring accuracy, enabling effective disease monitoring and management in IBD.
New scoring systems for assessing disease activity are developing, however, they are relatively unknown among gastroenterologists and are not yet widely used in clinical practice.
In the CONCORDIA study, the investigators will evaluate gastroenterology fellows' familiarity with these new scoring systems and assess whether structured endoscopic video assisted training improves scoring accuracy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The CONCORDIA study will be conducted in three sequential time periods. During Time Period 1 (two months), all participants will independently score 15 endoscopic videos using the updated Rutgeerts score and 15 videos with ePDAI and SES-pouch, supplemented with a general Visual Analogue Scale (VAS) score (0=no inflammation, 10=most severe inflammation). No specific guidance will be provided during that phase. Following the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (one months), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training.
| Arm | Type | Receives |
|---|---|---|
| Group A (Early training) | Active comparator | Other: TrainingFollowing the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (approximately one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. |
| Group B (Late training) | No intervention | –After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (approximately one month), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training module. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Gastroenterology fellows
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| TrainingA structured teaching module for fellows in training will be prepared and conducted at three university centres, namely University Hospitals Leuven, Ljubljana University Medical Centre, and CHU de Bordeaux. The training module will include short endoscopic videos (different from the pre- and post-training set), which participants will score in real-time using a polling application. This will be followed by a step-by-step demonstration of each scoring principle with explanations of the reasoning behind specific scores. Each scoring system will be reviewed in a short training video that provides a structured demonstration, highlights common pitfalls, and showcases typical IBD-associated endoscopic features. After the video training, participants will have the opportunity to ask questions to the experts. | Other | Group A (Early training) |
Primary outcome
Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos
Time frame: 3 months
In substudy A, the investigators will focus on the updated Rutgeerts score for patients with Crohn's disease that previously underwent an ileocolonic resection with ileocolonic anastomosis.
Improvement of ePDAI scoring accuracy after training with structured educational videos
Time frame: 3 months
In substudy B, the investigators will focus on the Endoscopic element of the Pouchitis Disease Activity Index (ePDAI) for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). ePDAI consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration.
IImprovement of SES-pouchitis scoring accuracy after training with structured educational videos
Time frame: 3 months
In substudy B, the investigators will focus on the Simple Endoscopic Score (SES)-pouchitis for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). SES-pouchitis evaluates four key parameters, ulcer size, ulcerated surface, affected surface area, and luminal narrowing, in the ileal pouch.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No. The primary objective of this study is to set-up a training for gastroenterology fellows
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with IBD (Inflammatory Bowel Disease), run by Universitaire Ziekenhuizen KU Leuven.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Ferrante (+3216344225 ext. +32, marc.ferrante@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2025.