Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Objectives: To assess the predictive value of IUS in children with IBD.

      Design: A prospective longitudinal cohort study.

      Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's
      Hospital.

      Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with
      either CD or UC.

      Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year
      follow-up according to therapeutic regimen.

      Secondary outcome measures: Correlation of sonographic measures to clinical disease indices,
      serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other
      radiologic measures performed as part of routine care.
    

Detailed description: 
      Hypothesis:

      The investigators hypothesize that bowel wall thickness as measured routinely by IUS has a
      role in predicting short- and long-term disease outcomes such as flares, hospitalizations,
      treatment escalation and surgery.

      Objectives:

      Primary Objectives:

      To assess the changes in bowel wall thickness, assessed by IUS, during 2-year follow-up,
      according to therapeutic regimen and to evaluate its predictive significance on disease
      outcomes (flares, hospitalizations, treatment escalation and surgery).

      Secondary Objective: To evaluate the correlation of sonographic measures to clinical disease
      indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and
      other radiologic measures performed as part of routine care.

      Methods:

        -  Design: A prospective longitudinal cohort study.

        -  Patients: Children at age 2 year to 17 years diagnosed with IBD.

      Intervention:

      Children diagnosed with either CD or UC under follow-up at the Institute of Gastroenterology,
      Nutrition and Liver Diseases, Schneider Children's Hospital, will be enrolled. Patients can
      be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics
      will be retrieved from their medical files including demographic details, disease phenotype,
      endoscopic and radiologic variables, anthropometric measures, laboratory evaluation,
      complication and therapeutic regimens. At enrollment and every 3 months for a total period of
      2 years all patients will perform IUS during regular clinic visits. All other measures
      including laboratory exams, anthropometric measurements and disease activity indices (either
      wPCDAI for CD or PUCAI for UC) will be performed as part of standard of care and not for the
      purpose of the study. If endoscopic evaluation or an MRE are necessary according to the
      treating physician discretion for assessment of disease activity, these will not be performed
      as part of the study but the results will be recorded and included in the data analysis.

      Data analysis:

      Data will be analyzed using SPSS (version 23.0, SPSS, Inc., Armonk, NY, USA) and r-project
      version 3.1.1. Continues variables will be presented as either mean±SD or median with
      interquartile range (IQR) depending on the data approximation to normal distribution.
      Agreement between IUS and MRE (when available) will be assessed using Bland-Altman plot and
      Concurrent Validity quantified by correlation coefficient and concordance correlation
      coefficient. Associations of therapeutic intervention and other variables with outcome
      measures will be examined using repeated measures ANOVA. p-values <0.05 is considered
      significant.

      Sample size:

      All pediatric IBD patients at Schneider Children's Hospital, fulfilling the inclusion
      criteria are eligible for the study. For assessment of therapeutic interventions of IUS the
      investigators will use mixed model ANOVA. Sample size was calculated for repeated measures
      ANOVA with in-between interactions. Assuming effect size F 0.25 (or partial η2=0.06), an
      alpha of 5% and statistical power of 80% and a correlation of 0.5, the investigators will
      need at least 34 CD patients and 34 UC patients.
    

Intervention name(s): Intestinal ultra-sound monitoring
Intervention type(s): Device
Intervention description(s): Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 2 years to 17 years who have been diagnosed at the Schneider Children's Hospital
        with either Crohn's disease or ulcerative colitis.