PANenteric Crohn's Capsule Versus Ileo-Colonoscopy and Scan Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Positive yields in Crohn's capsule vs ileo-colonoscopy and magnetic resonance enterography.
研究概览
简要总结
Crohn's disease (CD) is a lifelong condition affecting the small and/or large bowel, causing diarrhoea, abdominal pain and weight loss. Patients with CD receive two tests to assess if the patients' CD is active, namely ileo-colonoscopy (camera examination of the large bowel, IC) and a scan of the small bowel (MRE). Together, these tests help determine if the patients' symptoms are due to CD, which is important as the medication to heal the bowel is strong. But, these investigations are uncomfortable, embarrassing, time-consuming and involve hospital visits to two separate departments.
A new test involves swallowing a miniature camera, the size of a large vitamin pill (PillCam™ Crohn's (PCC)) that video-records the lining of the small and large bowel. Images are sent to a recorder worn over the tummy. The investigators aim to find out if the PCC capsule delivers a single test that is comparable to current tests (IC+MRE) for patients with CD.
125 patients with CD referred for IC+MRE will be recruited from 3 NHS hospitals. Each patient will undergo all three tests (IC+MRE and PCC). As there is a small risk of the capsule getting stuck (up to 3 in 100 patients), all patients will have a "dummy" capsule to check that the "real" capsule can travel safely through the bowel. If successful (checked with a handheld scanner and CT scan if required), patients proceed to PCC. Patients will receive bowel preparation (a drink to clean the bowel) prior to IC and PCC.
The investigators will compare the findings of all three tests. The investigators will interview patients to find out their experiences to inform the way the test is introduced into practice. When consulted, local patients with CD felt the research question is extremely important and all preferred having one non-invasive test over two invasive and uncomfortable tests.
详细描述
Purpose and design
Aims:
To determine if the PillCam™ Crohn's capsule (PCC) performs similarly to ileo-colonoscopy (IC) and magnetic resonance enterography (MRE) when assessing patients with an established diagnosis of Crohn's disease (CD).
Objectives:
Primary objective: To assess the number of positive results showing active disease which are detected ("positive yields") by PCC compared to IC and MRE in patients with an established diagnosis of CD.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75
- •Established diagnosis of Crohn's disease
- •Patients who have been referred for IC and MRE for CD assessment as deemed appropriate by referring clinician as part of standard care
排除标准
- •Indeterminate colitis or ulcerative colitis
- •Stricturing disease - history consistent with obstruction e.g. nausea, vomiting, abdominal pain, bloating after meals or stricture seen on previous imaging
- •Enteric fistulating disease based on clinical examination or previous imaging (perianal fistulae alone is allowed in the absence of anal strictures)
- •Previous small bowel or colonic resection within 12 months
- •Known or suspected bowel dysmotility
- •Previous pelvic radiotherapy
- •Insulin-treated diabetes mellitus
- •Pregnancy
- •Recent non-steroidal agent use within 4 weeks of study entry (excluding aspirin <150mg per day)
- •Contraindications to MRE, IC or capsule endoscopy
- •Contraindications to taking bowel preparation
结局指标
主要结局
Positive yields in Crohn's capsule vs ileo-colonoscopy and magnetic resonance enterography.
时间窗: 4-6 weeks
To assess the rate of macroscopically detectable disease or "positive yields" by the PillCamTM Crohn's capsule compared to ileo-colonoscopy and magnetic resonance enterography in patients with an established diagnosis of Crohn's disease.
次要结局
- Correlation between colonic scoring systems.(4-6 weeks)
- Positive diagnostic yield of Crohn's capsule with clinical severity of Crohn's disease.(4-6 weeks)
- Correlation between small bowel scoring systems.(4-6 weeks)
- Positive diagnostic yield of Crohn's capsule with patient quality of life.(4-6 weeks)
- Patient experience in each modality.(4-6 weeks)