跳至主要内容
临床试验/NCT06961942
NCT06961942尚未招募不适用

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

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 40 人开始时间: 2025年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Gastroenterology fellows

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Training (Other)

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.

结局指标

主要结局

Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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