Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Muenster、德国、48149
- University of Muenster, Dept. of Medicine B
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Exclusion Criteria:
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
- Patient is pregnant
- Patient has had prior abdominal surgery of the GI tract
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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UC
Patients with known ulcerative colitis
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PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends.
It is 31.11
mm in size and takes pictures at a rate of 4 frames per second.
The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
Standard Colonoscopy: Pts.
undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
大体时间：12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
大体时间：12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员：Tobias Meister, MD、University of Muenster, Dept. of Medicine B
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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PillCam Colon Capsule的临床试验
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Groupe d'Etude Therapeutique des Affections Inflammatoires...主动，不招人
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Military University Hospital, PragueInstitute for Clinical and Experimental Medicine; Masaryk University; University Hospital Hradec...未知