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

NCT ID: NCT06705972

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-10-31

Brief Summary

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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

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* 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

Conditions

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Inflammatory Bowel Disease (IBD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Martina Mamdouh Zekry Ayoub

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Martina Mamdouh zekry

Role: CONTACT

Marwa mohammed samy, Associate professor

Role: CONTACT

+20 01025260404

References

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Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.

Reference Type BACKGROUND
PMID: 35927032 (View on PubMed)

Valette PJ, Rioux M, Pilleul F, Saurin JC, Fouque P, Henry L. Ultrasonography of chronic inflammatory bowel diseases. Eur Radiol. 2001;11(10):1859-66. doi: 10.1007/s003300101065.

Reference Type BACKGROUND
PMID: 11702118 (View on PubMed)

Allocca M, Dell'Avalle C, Craviotto V, Furfaro F, Zilli A, D'Amico F, Bonovas S, Peyrin-Biroulet L, Fiorino G, Danese S. Predictive value of Milan ultrasound criteria in ulcerative colitis: A prospective observational cohort study. United European Gastroenterol J. 2022 Mar;10(2):190-197. doi: 10.1002/ueg2.12206. Epub 2022 Mar 1.

Reference Type BACKGROUND
PMID: 35233934 (View on PubMed)

Dragoni G, Gottin M, Innocenti T, Lynch EN, Bagnoli S, Macri G, Bonanomi AG, Orlandini B, Rogai F, Milani S, Galli A, Milla M, Biagini MR. Correlation of Ultrasound Scores with Endoscopic Activity in Crohn's Disease: A Prospective Exploratory Study. J Crohns Colitis. 2023 Oct 20;17(9):1387-1394. doi: 10.1093/ecco-jcc/jjad068.

Reference Type BACKGROUND
PMID: 37023010 (View on PubMed)

Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129.

Reference Type BACKGROUND
PMID: 32614386 (View on PubMed)

Other Identifiers

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Role of ultrasound in IBD

Identifier Type: -

Identifier Source: org_study_id

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