A Randomized Controlled Trial Comparing Endoscopic Ultrasound Evaluation Versus Esophagogastroduodenoscopy in the Diagnosis of Portal Hypertension in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Diagnosis of portal hypertension
研究概览
简要总结
Liver cirrhosis with the further development of portal hypertension implies structural and vasculature alteration in the portosplenic circulation.
Esophagogastroduodenoscopy is the standard of care for the detection and treatment of esophageal varices, as esophageal varices serve as a surrogate for estimating a portal pressure gradient > 10 mmHG.
Endoscopic ultrasound evaluation allows the detection of peri-esophageal collateral veins, perforating veins and para-esophageal collateral veins, which has demonstrated to be effective for the prediction of esophageal varices recurrence after variceal eradication.
The investigators aimed to compare esophagogastroduodenoscopy versus endoscopic ultrasound evaluation for the early diagnosis of portal hypertension in cirrhotic patients.
详细描述
A randomized control trial of 70 cirrhotic patients randomly submitted for esophagogastroduodenoscopy (35 patients) or EUS evaluation (35 patients) for the diagnosis of portal hypertension.
The portal pressure gradient will be defined based on portal vein catheterization via interventional radiology.
Esophagogastroduodenoscopy will evaluate the presence and grade of esophageal varices, presence and type of gastric varices, presence and signs of hypertensive gastropathy.
Endoscopic ultrasound will evaluate the presence of esophageal varices, the presence of gastric varices and the EUS- signs og hypertensive gastropathy, Azygos vein diameter, mean velocity and blood flow volume index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Above 18 years old
- •Willingness to participate in the study
- •Compensated liver cirrhosis based on clinical and imaging findings
- •Written informed consent provided
排除标准
- •Decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection
- •Hemodynamic instability
- •Pregant or nursing patients
- •Patients with history of esophageal, gastric, liver, pancreas and spleen tumors
- •Severe uncontrolled coagulopathy
- •Any contraindication for portal pressure gradient meassurement via radiological evaluation.
结局指标
主要结局
Diagnosis of portal hypertension
时间窗: During portal pressure gradient meassurement up to 4 weeks after randomization
Portal hypertension diagnosis based on portal pressure gradient
次要结局
- diagnostic accuracy of endoscopic ultrasound(during endoscopic ultrasound evaluation up yo 2 weeks after randomization)
- diagnostic accuracy of esophagogastroduodenoscopy(during esophagogastroduodenoscopy procedure up to 2 weeks after randomization)