A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Monitoring mucosal healing
研究概览
简要总结
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
详细描述
This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate:
- The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought.
- The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome;
- Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Crohn's Disease made at least 3 months before the enrolment;
- •subject was referred for endoscopic and imaging follow-up in Crohn's Disease
- •signed informed consent.
排除标准
- •Subject has dysphagia
- •Subject has renal insufficiency
- •Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
- •Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
研究组 & 干预措施
Pan-enteric capsule endoscopy (PCE)
Evidence of active disease by PCE prompted a change in therapy at the discretion of the treating clinician and according to current available pediatric guidelines. The definition of medical treatment adjustment after evidence of inflammation was: the introduction of steroids or enteral nutrition, the introduction or optimization of immunosuppressives; the introduction, optimization of biologics; or the introduction of both immunosuppressive agents and biologics. In case of a negative PCE and presence of symptoms, the magnetic resonance enterography (MRE) could help in guiding therapeutic decisions.
干预措施: Pan-enteric Capsule Endoscopy (PCE) (Device)
结局指标
主要结局
Monitoring mucosal healing
时间窗: 52 weeks
-The ability of PCE to assess mucosal healing rate (percentage of patients with healing of the mucosa) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD
Monitoring deep remission
时间窗: 52 weeks
-The ability of PCE to assess deep remission rate (percentage of patients with healing of the mucosa and absence of symptoms) at three time points and to guide a treat-to-target strategy was the primary outcome sought. and colonic CD
次要结局
- Treat to Target(52 weeks)
- Diagnostic Yield(52 weeks)
研究者
Salvatore Oliva
Research Assistant
Azienda Policlinico Umberto I