A controlled multicentre study comparing early treatment with polytetrafluoroethylene (PTFE) covered stents (Viator) versus optimised medical treatment in patients with cirrhosis and a high risk variceal bleeding episode

Individual Sponsor (Spain)0 个研究点目标入组 64 人开始时间: 2006年3月24日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male and female patients 18 - 75 years of age
•2. History of cirrhosis (clinical or by liver biopsy)
•3. Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
•4. Child-Pugh Class C or Child-Pugh class B plus active bleeding at endoscopy under pharmacological treatment
•5. Signed written informed consent

•1. Patients not fulfilling inclusion criteria
•2. Pregnancy
•3. Confirmed hepatocellular carcinoma with any of the following characteristics:
•3.1. One nodule of more than 5 cm
•3.2. More than 3 greater than 3 cm
•3.3. Perihiliar
•4. Creatinine greater than 3 mg/dl
•5. Terminal hepatic failure (Child-Pugh score greater than 13)
•6. Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
•7. Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
•8. Portal vein cavernoma
•9. Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
•10. Spontaneous recurrent hepatic encephalopathy

发起方

Individual Sponsor (Spain)