Early Transjugular Intrahepatic Portosystemic Shunt With Polytetrafluoroethylene Covered Stents Versus Standard Medical Therapy for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of survival without liver transplantation
研究概览
简要总结
The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •History of cirrhosis (clinical or by liver biopsy)
- •Admission due to acute bleeding from oesophageal or gastric (GOV1 or GOV2) varices
- •Child-Pugh Class C (Child-Pugh score less than or equal to 13) or Child-Pugh class B
- •Signed written informed consent
排除标准
- •Patients not fulfilling inclusion criteria
- •Pregnancy or breast-feeding
- •Confirmed hepatocellular carcinoma
- •Creatinine greater than 3 mg/dl
- •Terminal hepatic failure (Child-Pugh score greater than 13)
- •Previous treatment with TIPS or combined pharmacological and endoscopic treatment to prevent rebleeding
- •Fundal or ectopic gastric variceal bleeding (IGV1 or IGV2)
- •Complete portal vein thrombosis or portal cavernoma
- •Congestive heart failure New York Heart Association (NYHA) greater than III or medical history of pulmonary hypertension
- •Spontaneous recurrent hepatic encephalopathy
研究组 & 干预措施
TIPS treatment
Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).Vasoactive drugs will be continued until the TIPS is performed and antibiotics will be continued for 5-7 days.
干预措施: TIPS treatment (Procedure)
Medical treatment
Initial control of the bleeding episode will be obtained by vasoactive drugs (octreotide, somatostatin or terlipressin), endoscopic band ligation (sclerotherapy if technically difficult or not feasible) and prophylactic antibiotics.Patients will be treated with non-selective beta-blockers (propranolol)on day 5. In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers) and the only treatment to prevent rebleeding will be endoscopic band ligation.
干预措施: Medical treatment (Drug)
结局指标
主要结局
Number of survival without liver transplantation
时间窗: 2 years
次要结局
- Number of participants failed to control acute variceal bleeding within 5 days, 6 weeks and 1 year(1 years)
- Number of bleeding related death(2 years)
- Number of other portal hypertension related complications on follow-up (ascites, hepatorenal syndrome, hepatic encephalopathy)(2 years)
研究者
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China