Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- number of discordant films between the two capsules with two different readers
研究概览
简要总结
Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.
详细描述
Objectives
Main objective
To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6
Secondary objectives
To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years old
- •obscure digestive bleeding justifying capsule endoscopy
- •complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
- •absence of concomittent ongoing study
- •absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
- •filled inform consent
- •no implanted pace maker
- •patient being affiliated to the CPAM
排除标准
- •under 18 years old
- •oral iron within 8 days before capsule endoscopy
- •gastroparesis
- •pacemaker
- •swallowing troubles
- •presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy
- •pregnancy or risk of pregnancy without efficient oral contraception
- •absence of written informed consent
结局指标
主要结局
number of discordant films between the two capsules with two different readers
时间窗: 14 days
Reading of the two capsules film is randomized order by two different readers in each center
次要结局
未报告次要终点
研究者
Jean Christophe Saurin
Proffessor
Hôpital Edouard Herriot