NCT01079416已完成不适用
Is Capsule Endoscopy Accurate and Cost-effective Enough to Screen Cirrhotic Patients for Varices & Other Lesions?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The accuracy of capsule endoscopy for detecting esophageal varices
研究概览
简要总结
Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this study was to determine whether esophageal capsule endoscopy is convenient and accurate as upper endoscopy for detection of esophageal varices and related lesions.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years and less than 86 years at the time of consent.
- •Clinically evident or biopsy proven cirrhosis.
- •No previous documented UGI bleeding due to peptic ulcers, varices, portal hypertensive gastropathy, angiomas, or watermelon stomach.
- •No previous endoscopic, radiological or surgical treatment for variceal bleeding or ascites.
- •Probable life expectancy of at least 24 months without liver transplantation, as judged by the hepatologist and endoscopist-investigators, and have a Model for End-Stage Liver Disease (MELD) score ≤
- •Signed a written informed consent.
排除标准
- •Prior variceal bleeding- esophageal, gastric, or other site.
- •Prior endoscopic (e.g. sclerotherapy, ligation, or combination therapy), radiological (e.g. transjugular intrahepatic portosystemic shunt-TIPS) or surgical (e.g. portocaval or splenorenal shunt) treatment of esophagogastric varices or ascites.
- •Patient who was uncooperative or unable to give written consent.
- •Severe co-morbid illness, e.g. end stage chronic renal disease (e.g. dialysis dependence, creatinine greater than 2 times normal) or respiratory failure (e.g. ventilator dependent, oxygen dependent, unstable asthma or chronic obstructive pulmonary disease- e.g. 2 or more hospitalizations for exacerbation in 1 year, asthma or obstructive pulmonary disease which required daily bronchodilators and/or oral/inhaled steroids), tense ascites requiring repeated therapeutic paracenteses, severe hepatic encephalopathy, peritonitis, or sepsis.
- •Active cancer with less than a 24 month expected survival and/or cancer on active treatment with chemotherapy and/or radiation therapy.
- •Esophageal motility disorder, esophageal stricture or esophageal diverticulum, causing dysphagia or requiring dilatation.
- •GI obstruction or partial obstruction (by history or imaging), symptomatic GI stricture or pseudo-obstruction which may prevent passage of the capsule.
- •Patients with potentially reversible portal hypertension such as alcoholic hepatitis, acute viral hepatitis, untreated autoimmune hepatitis, or chronic hepatitis B or C on viral therapy.
结局指标
主要结局
The accuracy of capsule endoscopy for detecting esophageal varices
时间窗: June 2006-February 2008
次要结局
- Time to perform and interpret capsule endoscopy study(June 2006-February 2008)
研究者
Disaya Chavalitdhamrong
MD
University of California, Los Angeles
研究点 (1)
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