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

经颈静脉肝内门体支架分流术与优化药物治疗对肝硬化静脉曲张出血二级预防的比较

• 批准号: 14065852
• 负责人: Professor Dr. Tilman Sauerbruch
• 金额: --
• 依托单位: Klinik für Gastroenterologie, Stoffwechselerkrankungen und Internistische Intensivmedizin (Med. Klinik III)
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2005
• 资助国家: 德国
• 起止时间: 2004-12-31 至 2014-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/14065852?language=en
• 关键词: Covered; transjugular; intrahepatic; portosystemic; stent

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.

肝硬变患者经常出现食道静脉侧支扩张，即食道静脉曲张。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，再出血频繁(70%-80%)。因此，预防再出血是强制性的。这些患者目前的治疗方案(内窥镜下静脉曲张结扎术，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的无覆盖金属支架(TIPS))都存在重大缺点。这项随机对照多中心试验比较了两种预防再出血的方案：新开发的覆盖TIPS支架(A组)和血流动力学监测优化的医疗治疗(心得安加5-单硝酸异山梨酯药物治疗，在门脉压力降低不足的情况下将被内窥镜结扎术取代)(B组)。据推测，小直径覆盖的TIPS可以充分降低门静脉压力以防止再出血，但在放置TIPS后发生典型问题(肝功能衰竭、肝性脑病、TIPS功能障碍)的风险要低得多。第4页(共14页)本研究评估了这样一种假设，即与优化的标准治疗相比，这些优势转化为较低的再出血率(主要终点)。