Determining the Accuracy of Intestinal Ultrasound Scores as a Prescreening Tool in Crohn's Disease Clinical Trials.

INTRODUCTION: High rates of screen failure for the minimum Simple Endoscopic Score for Crohn's Disease (SES-CD) plague Crohn's disease (CD) clinical trials. We aimed to determine the accuracy of segmental intestinal ultrasound (IUS) parameters and scores to detect segmental SES-CD activity. METHODS: A single-center, blinded, cross-sectional cohort study of children and young adult patients with CD undergoing IUS and ileocolonoscopy, comparing segmental IUS bowel wall thickness (BWT), hyperemia (modified Limberg score [MLS]), and scores to detect segmental SES-CD activity: (i) SES-CD £2, (ii) SESCD ‡6, and (iii) SES-CD ‡4 in the terminal ileum (TI) only. Primary outcome was accuracy of BWT, MLS, and IUSscores to detect SES-CD£2andSES-CD‡6.Secondary outcomeswere accuracy of TIBWT,MLS, and IUS scores to detect SES-CD ‡4 and correlation with the SES-CD. RESULTS: Eighty-two patients (median [interquartile range] age 16.5 [12.9--20.0] years) underwent IUS and ileocolonoscopy of 323 bowel segments. Segmental BWT £3.1 mm had a similar high accuracy to detect SES-CD £2 as IUS scores (area under the receiver operating curve [AUROC] 0.833 [95% confidence interval 0.76--0.91], 94% sensitivity, and 73% specificity). Segmental BWT ‡3.6 mm and ‡4.3 mm had similar high accuracy to detect SES-CD ‡6 (AUROC 0.950 [95% confidence interval 0.92--0.98], 89% sensitivity, 93% specificity) in the colon and an SES-CD ‡4 in the TI (AUROC 0.874 [0.79--0.96], 80% sensitivity, and 91% specificity) as IUS scores. Segmental IUS scores strongly correlated with the SES-CD. DISCUSSION: Segmental IUS BWT is highly accurate to detect moderate-to-severe endoscopic inflammation. IUS may be the ideal prescreening tool to reduce unnecessary trial screen failures. [ABSTRACT FROM AUTHOR]