Comparing the Accuracy of Different Ultrasound-based Scores to Assess Disease Severity in Patients with Inflammatory Bowel Disease

Not yet recruiting

• Conditions: Inflammatory Bowel Disease (IBD)

• Registration Number: NCT06705972
• Lead Sponsor: Assiut University

Brief Summary

Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity The aim of research is to compare between different ultrasound based scores used to assess disease severity in patients with inflammatory bowel disease to determine the most accurate score to be validated to use in clinical practice

Detailed Description

* Infammatory Bowel Disease (IBD) is a lifelong chronic disease comprised of two main entities: Crohn's disease and Ulcerative Colitis. The former can involve any part of the gastrointestinal tract with marked mural infammatory change and frequent complications related to either a penetrating or fbrostenotic phenotype, while the latter is a superfcial inflammatory process involving only the colon. IBD can undergo spontaneous periods of remission and activity and has a full spectrum from mild inconsequential disease to incapacitating complications, which may alter both lifestyle and longevity

* IBD patients require repeat imaging throughout the course of their disease, necessitating a safe, noninvasive, available, and repeatable method. Imaging is required at diagnosis, routine surveillance, and acute flare of disease. Ultrasound imaging meets these demands with a high degree of accuracy and wide patient acceptance. Ultrasound provides high-resolution imaging and is excellent for detailed evaluation of the bowel wall and surrounding soft tissues performed without ionizing radiation with an extremely low risk of adverse contrast events compared to CT and MR Enterography which use ahigh dose of ionizing radiation, making it the frst choice of many Gastroenterologists and overwhelmingly preferred by patients

Several established IUS parameters are assessed during an IUS examination. These include bowel wall thickness (BWT); the stratification of the bowel wall layers, blood flow, luminal diameters, and motility, Additional extraintestinal surrogates to bowel inflammation to assess for include mesenteric fat proliferation and lymphadenopathy ,with proposal of different sonographic scoring systems in this domain to predict disease severity

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-12
• Primary Completion: 2025-01
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients aged 18-70 Confirmed diagnosis of Crohn's Disease or Ulcerative Colitis based on clinical, endoscopic, and histologic criteria

Exclusion Criteria

• Patients with other gastrointestinal diseases History of colectomy or proctocolectomy: Patients without a colon or rectum, which would limit the ability to assess IBD in those regions using ultrasound

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy of different ultrasound scores to assess disease severity in IBD patients	Baseline	To compare the efficacy of different ultrasound scoring systems in assessing disease severity in IBD patients.; To determine the correlation between ultrasound scores and clinical, endoscopic, and histological findings; .To identify the most reliable and practical ultrasound scoring system for routine clinical use