Enhancing Endoscopic Scoring Consistency and Accuracy in IBD: a Video-based Training Approach (CONCORDIA)

May 5, 2025 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gastroenterology fellows

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Early training)

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.
Other: Training
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.
No Intervention: Group B (Late training)

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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

May 5, 2025

First Posted (Actual)

May 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONCORDIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The primary objective of this study is to set-up a training for gastroenterology fellows

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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