Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis (ASC): A Prospective Multicenter Study From the Paediatric IBD Porto Group of ESPGHAN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
研究概览
简要总结
ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.
BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged < 18 years hospitalized for ASC with diagnosis of UC established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria
排除标准
- •Patients with infectious colitis;
- •Patients undergoing treatment with anti-TNF alpha agents;
- •Patients already enrolled during the study period for a previous ASC attack;
结局指标
主要结局
Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
时间窗: Within 48 hours from i.v. steroid treatment initiation
Colonic wall vascularization will be assessed according to the Limberg score to identify two subgroups: 1) increased vascularization (Limberg score 3-4); 2) normal colonic wall flow (Limberg Score 0-2). Such classification will be used, measured within the first 48 hours from i.v. steroid initiation, to predict failure of first line treatment (according to the latest ESPGHAN guidelines)
Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment
时间窗: Within 48 hours from i.v. steroid treatment initiation
Investigation of the ability of BUS (bowel ultrasound) parameters, such as Colonic wall thickness (CWT) measured in mm, assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines). CWT will be measured from the edge of the outer wall to the inner echogenic lumen, containing air, or to the central echogenic mucosal stripe. CWT will be assessed as follows: two measurement through longitudinal plain and two through tranverse plain will be performed and the mean value (the sum of each measurement divided for 4) will be taken into account
Mesenteric lymph nodes BUS (bowel ultrasound) parameter
时间窗: Within 48 hours from i.v. steroid treatment initiation
Presence of enlarged mesenteric lymph nodes, defined by short axis \> 5 mm it will be assessed within 48 hours from i.v. steroid treatment initiation, to predict the failure of first line treatment (defined according to the latest ESPGHAN guidelines)
次要结局
- evaluation of the prognostic value of the ultrasound parameters(Within 48 hours from second-line therapy initiation)
研究者
Paolo Lionetti
Full Professor, Head of Gastroenterology, Principal Investigator
Meyer Children's Hospital IRCCS