NCT05597488招募中不适用
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
研究概览
简要总结
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 75 years old
- •Informed consent available
- •Suffering from chronic hepatitis induced cirrhosis
- •Suffering from oesophageal varices and received EVL as a result of
- •Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
- •Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
- •Or bleeding gastric varices that have received endoscopic canoacrylate injection
排除标准
- •Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
- •Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).
- •Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation
- •- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.
- •Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
结局指标
主要结局
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
时间窗: 1 year
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
次要结局
- Other outcome measurements(1 year)
研究者
Anthony Teoh
Professor
Chinese University of Hong Kong
研究点 (1)
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