Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Portal vein blood flow volume
研究概览
简要总结
The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. In the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.
详细描述
126 patients will be enrolled in the study, 63 subjects will be randomized into the group A and the other will be into the group B.
Group A: endoscopic therapy and somatostatin treatment. Group B: endoscopic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •Cirrhosis with esophageal gastric varices needed endoscopic therapy
- •Age 18-75 years
- •Informed written consent
排除标准
- •Use of vasoactive drugs 24 hours before endoscopic treatment
- •Use of B-blocker within 1 week
- •Previous surgical or endoscopic treatment for esophageal gastric varices
- •Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy
- •Gastro-renal vein shunt
- •Severe hepatic hydrothorax
- •Hepatocellular carcinoma with portal vein thrombosis
- •Severe coagulation disorders
- •Severe active bacteria infection
- •Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure
- •Severe renal function insufficiency （Calculated Creatinine Clearance Rate (Ccr) <30ml/min）
- •Severe co-morbidity that would affect short-term prognosis
- •Pregnancy or lactation
- •Allergy to any ingredient of trial medication
- •Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
研究组 & 干预措施
endoscopic therapy
干预措施: endoscopic therapy (Procedure)
endoscopic and somatostatin treatment
干预措施: Somatostatin (Drug)
结局指标
主要结局
Portal vein blood flow volume
时间窗: change from baseline in portal vein blood flow volume after 7 days treatment
Note: 1. Portal vein blood flow volume will be measured by doppler ultrasound device. 2. Values are the mean of three consecutive measurements. 3. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. 4. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation.
次要结局
- Portal vein diameter (PVD mm)(change from baseline in PDV after 7 days treatment)
- Mean portal vein blood velocity (PVV cm/s)(change from baseline in PVV after 7 days treatment)
- Ascites volume(change from baseline after 7 days treatment)
研究者
Yunsheng Yang
chinese PLA General Hospital
Chinese PLA General Hospital