Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.
研究概览
简要总结
The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.
详细描述
Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.
The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
- •Age greater than or equal to 18 years old
- •Able to give consent
排除标准
- •Current implantable cardioverter-defibrillators or pacemaker in place
- •Suspected intestinal obstruction
- •Esophageal swallowing disorder
- •Esophageal stenosis
- •Age less than 18 years old
- •Pregnancy
- •Known Zenker's diverticulum
- •Patients with previous endoscopic or surgical esophageal treatment
研究组 & 干预措施
Capsule Endoscopy
干预措施: Esophageal Capsule Endoscopy (Device)
Upper Gastrointestinal Endoscopy
干预措施: Upper Gastrointestinal Endoscopy (Device)
结局指标
主要结局
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.
时间窗: Two years
次要结局
- Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.(Two years)