A Comparative Study of Capsule Endoscopy, Magnetic Resonance Imaging and Computer Tomography Scanning of the Small Bowel in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.
研究概览
简要总结
The aim of this study is to evaluate three diagnostic methods for assessing small bowel disease in patients with suspected or known Crohn's disease. All patients are examined with ileo-colonoscopy, capsule endoscopy, MRI and CT of the small bowel within 14 days. However, capsule endoscopy is not performed in patients with stenosis detected at ileo-colonoscopy, MRI and/or CT. All investigations are described in a similar pre-defined and standardized fashion and the radiologist and physician responsible for describing the findings at MRI, CT and capsule endoscopy are blinded to the findings at ileo-colonoscopy. The physician in charge of treatment receives a randomised result of either MRI, CT or capsule endoscopy. Thereafter patients are followed during 12 months to evaluate differences in clinical outcome depending on the randomized result. In combination with the diagnostic validity and inter-observer agreement of MRI, CT and capsule endoscopy we seek to establish the optimal diagnostic strategy in these two patient categories.
详细描述
OVERALL AIM OF THE STUDY To evaluate three diagnostic methods for assessment of intestinal disease in patients with suspected or newly diagnosed Crohn's disease and patients with known Crohn's disease.
PARTICIPATING CENTRES
- Department of Medical Gastroenterology, Odense University Hospital, DK-5000 Odense C
- Department of Internal Medicine, section of Gastroenterology, Vejle Hospital, DK-7100 Vejle
- Department of Internal Medicine, section of Gastroenterology, Sydvestjysk Hospital, DK-6700 Esbjerg
- Department of Internal Medicine, section of Gastroenterology, Svendborg Hospital, DK-5700 Svendborg
- Department of Radiology, Vejle Hospital, DK-7100 Vejle
PROTOCOL A
A comparative study of capsule endoscopy, magnetic resonance imaging and computer tomography scanning of the small bowel in patients with suspected or newly diagnosed Crohn's 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
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General criteria:
- •Age > 15 years
- •Written informed consent
- •Patients with established CD are included if assessment of small bowel disease was necessary prior to expected surgery or a change in medical therapy.
- •Patients with suspected CD are included on either clinical, endoscopical or histological criteria or a combination of these.
- •Clinical criteria: Diarrhoea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhoea and/or abdominal pain) associated with one or more of the following findings: CRP > 5 mg/l, thrombocytosis, anaemia, fever, weight loss, perianal abscess/fistula or a family history of inflammatory bowel disease.
- •Endoscopical criteria (at least one): Ulcerations and/or stenosis in the terminal ileum, inflammation in the colon not involving the rectum, and aphthous ulcerations in the colon.
- •Histological criteria (at least one): Epitheloid cell granulomas, chronic inflammation in the lamina muscularis mucosae or deeper and chronic inflammation in the colon not involving the rectum.
排除标准
- •Acute bowel obstruction, elevated serum-creatinine, severe claustrophobia, cardiac pacemaker, implanted magnetic foreign bodies, use of NSAID's, pregnancy and lactation
结局指标
主要结局
Sensitivity and specificity for CT scanning of the small bowel, MRI of the small bowel and CE.
时间窗: February 2010
次要结局
- Interobserver variation for capsule endoscopy, MRI and CT scanning of the small intestine Patient experienced discomfort(February 2010)
研究者
Michael Dam Jensen
Dr
University of Southern Denmark