A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
研究概览
简要总结
This study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. Patients aged 4-25 years of age will be recruited.
In this study, the Investigator hopes to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). Additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosis of inflammatory bowel disease (IBD) or patients who have an established diagnosis of IBD and are experiencing an acute flare which is not being controlled with first line therapy
- •Patients present with typical IBD symptoms which will include, but are not limited to, abdominal pain, loss of appetite, rectal bleeding, diarrhea, obstruction, or passage of mucus.
- •Patients referred by the GI team.
- •Patients (or guardians/parents) must be able and willing to give consent (or assent where applicable) and be able to attend all study visits.
排除标准
- •Patients with MR unsafe metallic implants that will not be able to undergo the MRI portion of the study.
- •Patients with renal function impairment (GFR < 45 mL/min) preventing contrast administration.
- •Patients with contrast allergy.
研究组 & 干预措施
Methylprednisolone
Participants who have failed first line therapy and are still experiencing flare symptoms.
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Number of patients with symptomatic, imaging or biopsy related improvement in their IBD symptoms
时间窗: Baseline through week 6
Number of patients who have symptomatic, imaging or biopsy related improvement in their IBD symptoms following locoregional intraarterial methylprednisolone administration into the affected segment of bowel.
次要结局
- Number of patients in which pre-procedural and procedural imaging can be correlated with clinical outcomes following therapy(Month 6)
- Number of patients who have molecular changes correlated with improvement in symptoms following intraarterial steroid therapy.(Month 6)
研究者
Avnesh Thakor
Associate Professor of Radiology
Stanford University