Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin
研究概览
简要总结
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
详细描述
Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.
These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.
Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.
Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.
The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age is 18 years or older
- •Patient agrees to sign the Informed Consent Form
- •Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:
- •Chronic diarrhea
- •Weight loss
- •Abdominal cramps
- •History of spontaneous abortion
- •Iron deficiency anemia
- •Osteoporosis
- •Infertility
- •Hypoalbuminaemia
- •Low cholesterol
- •Low prothrombin activity
排除标准
- •Patient is known or is suspected to suffer from intestinal obstruction.
- •Patient has a cardiac pacemaker or other electro-medical device.
- •Patient suffers from severe swallowing disorder or Zenker's diverticulum
- •Patient has any condition, which precludes compliance with study and/or device instructions.
- •Female patient is pregnant
- •Patient suffers from life threatening conditions
- •Patient is currently participating in another clinical study.
结局指标
主要结局
The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin
时间窗: within 14 days of enrollment
次要结局
- Longitudinal extent of villous changes in the small bowel will be evaluated.(within 14 days of enrollment)