Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents in Cirrhotic Patients: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- hepatic encephalopathy incidence:
研究概览
简要总结
Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective portal pressure reduction (essential in the treatment of those pathologies in which TIPS is indicated) still do not exist.
Aim of the study The purpose of our study is to compare the clinical efficacy and the incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with hepatic cirrhosis.
详细描述
Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents in Cirrhotic Patients:
A Randomized Controlled Study
Introduction In the treatment of esophageal varices rebleeding1 and ascites/hydrothorax refractory to the diuretic therapy2 by transjugular intrahepatic portosystemic shunt (TIPS), shunt stenosis (occurring in 30-70% of cases during the first post-procedural year) and the onset of hepatic encephalopathy (30-55% of cases at one year) represent two major problems.
Since the year 2000, a new polytetrafluoroethylene covered stent has highly improved TIPS patency, thus inducing a remarkable reduction of rebleeding incidence. Some authors, however, suggest that the maintenance of the shunt patency may involve an increased risk of hepatic encephalopathy, although the data in the present literature are limited and controversial. The only randomized controlled study3 available, in fact, reports a lower incidence of hepatic encephalopathy in those patients treated with covered stents as compared with those treated with conventional metallic stents. In our preliminary experience,4 instead, a similar incidence of hepatic encephalopathy was noted in both groups. In addition, in the group of patients treated by covered stents, a higher number of cases with persistent and intractable hepatic encephalopathy (requiring shunt reduction) was recorded.5 Post-TIPS hepatic encephalopathy incidence increases with the decrease of post-procedure portal pressure which depends on the caliber of the stent used to create the anastomosis. This might suggest the use of covered stents with a smaller diameter aimed at reducing the risk of hepatic encephalopathy. Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective portal pressure reduction (essential in the treatment of those pathologies in which TIPS is indicated) still do not exist.
Aim of the study The purpose of our study is to compare the clinical efficacy and the incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with hepatic cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All consecutive cirrhotic patients who have undergone TIPS at our Department for bleeding of esophagogastric varices refractory to medical or endoscopic treatment or for ascites/hydrothorax refractory to diuretic therapy will be considered eligible for the study.
排除标准
- •an age >75 years; past or present history of hepatic encephalopathy;
- •a Z-score at trial making test-A (TMT-A) >1.5;
- •bilirubine levels >5 mg/dl;
- •creatinine levels >3 mg/dl;
- •serious cardiac or pulmonary dysfunction;
- •a Child-Pugh's score >11;
- •a model end-stage liver disease (MELD) score >18;
- •portal thrombosis;
- •a diagnosis of hepatic carcinoma;
- •spontaneous bacterial peritonitis;
- •renal insufficiency.
结局指标
主要结局
hepatic encephalopathy incidence:
时间窗: 1 year
次要结局
- incidence of persistent hepatic encephalopathy: defined as the presence of a continuous mental state alteration, with episodes of further worsening episodes;(one year)
- incidence of recurrent hepatic encephalopathy: defined as the onset of at least three episodes of open hepatic encephalopathy in a six-month period;(one year)
- shunt dysfunction: defined as the finding of a portosystemic gradient higher than 12 mm Hg and angiographic evidence of shunt stenosis or occlusion;(one year)
- incidence of variceal rebleeding: defined as the finding, at esophagogastroduodenoscopy, of ongoing or recent variceal hemorrhage or the finding of blood in the stomach and the presence of varices as the only potential cause of bleeding;(one year)
- recurrence of ascites: defined as the need of performing at least one evacuation of ascitic fluid with paracentesis;(one year)
- survival: all deaths of any cause will be recorded. All mortalities occurring within a six-week period from a digestive bleeding episode will be considered as related to the bleeding itself. All deaths occurring within 30 days post-TIPS placement will(one year)