Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
研究概览
简要总结
The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and at the third month of treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.
详细描述
The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. Active lesions under intestinal color ultrasound were defined as SUS-CD ≥ 1, and active lesions under capsule endoscopy were defined as CECDAI ≥ 3.9. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and 3 months after treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease;
- •2.At the time of inclusion, there were active lesions under color ultrasound or capsule endoscopy;
- •3.Voluntarily sign an informed consent form.
排除标准
- •1.Patients with contraindications for capsule endoscopy;
- •2.In the judgment of the investigator, it is not suitable to participate in this study.
结局指标
主要结局
the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
时间窗: at the third month of treatment
The CECDAI was designed to evaluate three main parameters of Crohn's disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI =(\[A1×B1\] +C1) +(\[A2×B2\] +C2).
the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)
时间窗: at the third month of treatment
The Simple Ultrasound Score for Crohn's Disease \[SUS-CD\] is constituted by Bowel wall thickness (BWT) and colour Doppler. BWT：\<3 mm gets 0 score, 3 to 4.9 mm gets 1 score, 5 to 7.9 mm gets 2 scores, and intestinal wall thickness of ≥8 mm gets 3scores. Colour Doppler score：No or single vessel gets 0 score, 2-5 vessels per cm2 gets 1 score, \>5 vessels per cm2 gets 2 scores.
次要结局
未报告次要终点