Calculating the LEmann IndeX Using InTEstiNal Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD.
研究概览
简要总结
The goal of this clinical trial is to assess and quantitatively measure structural bowel damage in Crohn's disease (CD) with the Lèmann-Index (LI) for Intestinal Ultrasound (IUS). IUS is a non-invasive, easily repeated and well tolerated tool with no bowel preparations. With this study the investigators aim to show that IUS can replace Magnetic Resonance Enterography (MRE), which has been used to develop the original Lèmann-Index, to evaluate structural bowel damage.
For each patient, IUS and MRE (and Colonoscopy, if the colon is involved) will be performed within a two-month timeframe.
详细描述
EXTENT will be a multicenter, cross-sectional study including 102 Crohn's disease (CD) patients, stratified by known or suspected CD location (small bowel and colon) and by disease duration (< 2 years, ≥ 2 years and < 10 years, and ≥ 10 years). The investigators will recruit patients with an established diagnosis of CD, with no restriction per disease activity, surgical history or CD medication.
Enrolled participants will undergo baseline blood work, stool studies, and both MRE and IUS.
Individuals with colonic involvement will also undergo colonoscopy. Patients will also answer to the IBD disability index questionnaire to assess the patients' functional status. All examinations performed will be standard of care, needed for patient monitoring, and the results will be used for the purpose of this study. Clinical data, imaging and colonoscopy assessments will be collected from participants prospectively over a period of 8 weeks. IUS and MRE data will be centrally read by three central readers blinded to the local reader grading of lesions.
The primary objective is to demonstrate that IUS can replace MRE to evaluate small bowel global damage and colon global damage (excluding rectum) in Crohn's disease patients with small bowel and/or colonic involvement.
Additive objectives concerning IUS versus MRE are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.
- •Patients with a previously documented CD diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria.
- •Age ≥18 years old.
- •Examinations needed as standard of care.
排除标准
- •Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period
- •Patients with a primary diagnosis of ulcerative colitis or IBD unclassified or microscopic colitis
- •Patients with disease limited to the upper GI tract, rectum or perianal CD
- •Patients with a contraindication for MR, colonoscopy and/or ultrasound
- •Patients with allergy to gadolinium chelated or with eGFR<60 mL/min/1.73m2
- •Patients unwilling or unable to provide informed, written consent.
结局指标
主要结局
Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD.
时间窗: Baseline
次要结局
- Intraclass correlation between the LI-IUS and LI-MRE segmental damage scores (terminal ileum) and LI-IUS and LI-MRE+colonoscopy (all colonic segments, except rectum).(Baseline)
- Intraclass correlation between the LI-IUS scores and the LI-MRE + colonoscopy scores in assessing colon damage in patients with CD.(Baseline)
- Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD.(Baseline)
- Intraclass correlation between the small bowel, colon and global LI-IUS and LI-MRE scores by local investigators and central readers.(Baseline)
- Acceptability rate of IUS, MRE and colonoscopy.(Baseline)
- Intraclass correlation between the evaluations of small bowel and colon LI-IUS damage scores between central readers.(Baseline)
- Intraclass correlation between the evaluations of small bowel and colon LI-MRE damage scores between central readers.(Baseline)
- Intraclass correlation between repeated evaluations of small bowel and colon LI-IUS damage scores by central readers.(Baseline)
- Intraclass correlation between repeated evaluations of small bowel and colon LI-MRE damage scores by central readers.(Baseline)
- Correlation between IBD disability index and small bowel and colon damage scores, as evaluated by IUS or by MRE.(Baseline)
- Intraclass correlation between IUS and MRE for the presence and distribution of stricturing and penetrating lesions by central readers.(Baseline)