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Validation and Interobserver Reliability of a Simple Ultrasound Score for Crohn's Disease

NCT03481751 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2022-10-04

No results posted yet for this study

Summary

Crohn's disease (CD) is a chronic inflammatory disease in the gastrointestinal (GI) tract. It is characterized by an alternating course between remission and relapse, which necessitates subsequent adjustments in medical therapy. Thus, it is important to have suitable tools to assess disease activity, and currently the reference standard is using ileocolonoscopy. However, ileocolonoscopy causes major patient discomfort and due to logistic reasons, it cannot be performed on a regular basis. High frequency ultrasound (US) is a potentially useful tool to evaluate changes in disease activity in affected bowel segments. Although there are some studies using US in CD patients to construct ultrasonographic scoring systems, there are no validated scores in daily clinical practice. In a recent study by Nylund et al, we used multiple linear regression to select which simple conventional ultrasound parameters that should be included in an ultrasound scoring system (Simple Ultrasound Score of Crohn's Disease (SUS-CD)) using endoscopy as a reference (unpublished data). In this study, we aim to validate this scoring system using an endoscopic score (Simple endoscopic activity score for Crohn's disease (SES-CD)) as reference standard and to assess interobserver variability.

The scoring system might be a useful supplement to endoscopy to follow up CD patients.

Conditions

  • Crohn Disease
  • Ultrasound

Interventions

DIAGNOSTIC_TEST

Diagnostic test: Ultrasound

Transabdominal ultrasound of the bowel for categorization of disease activity

Sponsors & Collaborators

  • Alesund Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Kim Nylund, PhD · Haukeland University Hospital

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2020-12-20
Completion
2022-12-20

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481751 on ClinicalTrials.gov