TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 主要终点
- Cumulative incidence of clinically significant variceal rebleeding
研究概览
简要总结
Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment.
A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or > 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS.
The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.
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
- •Confirmed diagnosis of liver cirrhosis
- •Standard NSBB therapy was used for primary prophylaxis
- •At least 5 days after index variceal bleeding
- •Child-Pugh score <13, Model for end-stage liver disease score < 19
排除标准
- •Gastric variceal bleeding (GOV2，IGV1，IGV2)
- •History of shunt surgery
- •Degree of portal vein thrombosis > 50%
- •Refractory ascites
- •Budd-Chiari syndrome
- •Hepatocellular carcinoma or other malignant tumors
- •Uncontrolled infection
- •Pregnant or breast-feeding woman
- •Poor compliance
结局指标
主要结局
Cumulative incidence of clinically significant variceal rebleeding
时间窗: 12 months
Recurrent melena or hematemesis resulting in either hospital admission, blood transfusion, drop in hemoglobin of at least 3 g/L, or death within 6 weeks after rebleeding.
次要结局
- Cumulative incidence of hepatic encephalopathy (HE)(12 months)
- Cumulative incidence of variceal bleeding related mortality(12 months)
- Cumulative incidence of all cause mortality(12 months)
- Cumulative incidence of adverse events (AE)(12 months)
研究者
Tie Jun
Director of clinical research
Air Force Military Medical University, China