NCT00941421终止不适用
"Comparision of Diagnostic Value of Oesophagal Videocapsul (VCO) and Oeso-gastro-duodenal Fiber Endoscopy (OGDFE) for the Screening of Oesophagal Varix (OV) for Cirrhotic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 310
- 试验地点
- 11
- 主要终点
- Presence or not of oesophagal varix
研究概览
简要总结
The purpose of this study is to determine the equivalence or not of diagnosis ability of oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of oesophagal varix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18< age< 80
- •Diagnosis of a cirrhosis
- •suspicion of portal hypertension without known diagnosis of a cirrhosis
- •Able to give an inform consent
排除标准
- •Related to pouplation
- •case history of cancer or oesophagal surgery
- •case history of an ORL cancer
- •case history of evolutive cancer
- •Related to pathology
- •Previous fiberoptic endoscopy with OV diagnosis
- •Less than 6 month since last fiberoptic endoscopy
- •Related to tested device
- •clinical suspicion of oesophagal stenosis for a patient presenting a dysphagia to solids
- •Zenker diverticuls attested
- •clinical suspicion of small intestinal stenosis
- •patient with pace-maker or any other inter device
- •pregnant women
- •deglutition troubles withfalse passage and/or conscience troubles
研究组 & 干预措施
videocapsul and OGDFE
Other
Each patient have a Fiberoptic endoscopy by videocapsul, followed by one traditional oeso-gastro-duodenal fiberoptic endoscopy
干预措施: oesophagal videocapsule and oeso-gastro-duodenal fiberoptic endoscopy (Device)
结局指标
主要结局
Presence or not of oesophagal varix
时间窗: each fiberoptic endoscopy
次要结局
- Presence of OV with red signs(each exam)
- Presence of big VO or VO with red signs diagnosed by the two exams(each patient)
- Discrimination threshold for OV prediction(each exam)
- analogical visual scale for tolerance of each exam(30 days after last exam)
研究者
研究点 (11)
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