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

NCT03481751 | Unknown

• 1 other identifier: 2017/1750
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 3

Brief 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in an ultrasound scoring system (Simple Ultrasound Score of Crohn's Disease (SUS-CD)) using endoscopy as a reference (unpublished data).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

Keywords

Crohn Disease; Ultrasound; Monitoring; Disease activity

Outcome Measures

Primary Outcomes (1)

• Remission

  The primary outcome measure is clinical and biochemical remission at 12 months (defined as Simple index \<5, Calprotectin\<250, C reactive protein (CRP)\<5 and no steroids). For patients examined with ileocolonoscopy as part of regular follow up after 8-16 months the end-point will be mucosal healing (defined as SES-CD 0-2).

  Follow up period (12 months)

Study Arms (1)

Patients with Crohn Disease

Patients with Crohn's disease scheduled for ileocolonoscopy

Diagnostic Test: Diagnostic test: Ultrasound

Interventions

Diagnostic test: Ultrasound DIAGNOSTIC_TEST

Transabdominal ultrasound of the bowel for categorization of disease activity

Patients with Crohn Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease scheduled for assessment with ileocolonoscopy is considered as eligible, thus, the study population is heterogeneous. The ultrasonographic scoring system will be tested at different intestinal locations and disease activities, and consequently, a heterogeneous population is thus suitable.

You may qualify if:

• Patient with Crohn's Disease scheduled for ileocolonoscopy.

You may not qualify if:

• \<18 years
• \>75 years
• CD located in other areas than the terminal ileum or colon
• pregnancy
• chronic obstructive lung disease
• acute coronary heart disease
• clinically unstable heart disease
• ongoing gastroenteritis
• presence of an intra-abdominal abscess or a fistula
• obesity (BMI\>30 kg/m2)

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Alesund Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (3)

Department of Medicine, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Ålesund Hospital

Ålesund, Møre og Romsdal, Norway

Location

University Hospital of North Norway Tromsø

Tromsø, Troms, Norway

Location

Related Publications (1)

• Saevik F, Eriksen R, Eide GE, Gilja OH, Nylund K. Development and Validation of a Simple Ultrasound Activity Score for Crohn's Disease. J Crohns Colitis. 2021 Jan 13;15(1):115-124. doi: 10.1093/ecco-jcc/jjaa112.

  PMID: 32504533 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Kim Nylund, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: January 8, 2018
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

NO (3)