Covered transjugular intrahepatic portosystemic stent shunt versus optimezed medical treatment for the secondary prevention of variceal bleeding in cirrhosis

肝硬化患者常出现食管静脉侧支扩张，即食管静脉曲张。此类静脉曲张出血是这些患者死亡的主要原因之一。初次出血后，再出血是常见的（70 - 80%）。因此，再出血预防是强制性的。这些患者目前的治疗方案（内镜下静脉曲张结扎，旨在降低静脉曲张内血压的药物治疗，以及在肝静脉和门静脉分支之间插入减压无盖金属支架（TIPS））都有主要的缺点。目前的随机、对照、多中心试验比较了两种预防再出血的方案：插入新开发的覆盖tips支架（a组）和血流动力学监测的优化药物治疗（用普萘洛尔加异山梨酯-5-单硝酸酯进行药物治疗，在门静脉压力降低不足的情况下，用内窥镜静脉曲张结扎代替）（B组）。据推测，小直径覆盖的TIPS可以充分降低门静脉压力以预防再出血，但在TIPS插入后出现典型问题（肝衰竭、肝性脑病、TIPS功能障碍）的风险要低得多。与优化的标准治疗相比，本研究评估了这些优势转化为更低的再出血率（主要终点）的假设。

Patients with liver cirrhosis frequently develop dilated venous collaterals in the esophagus, i.e. esophageal varices. Bleeding from such varices is one of the major causes of death in these patients. After an initial hemorrhage, rebleeding is frequent (70 - 80 %). Thus, rebleeding prophylaxis is mandatory. Each of the current therapeutic options for these patients (endoscopic ligation of varices, drug treatment aimed at lowering the blood pressure inside the varices, and the insertion of a decompressive uncovered metal stent between the hepatic vein and a branch of the portal vein (TIPS)) carries major disadvantages. The present randomized, controlled, multicenter trial compares two regimens for rebleeding prophylaxis: the insertion of a newly developed, covered TIPS-stent (group A) and a hemodynamically monitored optimized medical treatment (drug treatment with propranolol plus isosorbide-5-mononitrate which will be replaced by endoscopic ligation of varices in case of an insufficient reduction of the portal pressure) (group B). Presumably, a small diameter covered TIPS induces sufficient portal pressure reduction for rebleeding prevention, but carries a much lower risk of typical problems after TIPS insertion (liver failure, hepatic encephalopathy, TIPS dysfunction). Page 4 of 14 This study evaluates the hypothesis that these advantages translate into a lower rebleeding rate (primary endpoint) when compared with optimized standard treatment.