Carvedilol Plus Endoscopic Cyanoacrylate Injection Versus Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Rebleeding From Gastric Varices
研究概览
简要总结
Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
详细描述
Gastric variceal bleeding is a lethal complication of portal hypertension. The rebleeding rate ranged between 30% to 50% in patients after initial hemostasis. Endoscopic cyanoacrylate injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding and prevention of recurrent bleeding. However, the rebleeding rate is still high in the patients undergoing repeated endoscopic cyanoacrylate injection.
Non-selective β-blockers are frequently used for the secondary prophylaxis of variceal bleeding. In the case of esophageal varices, combination of non-selective β-blockers and endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy alone. However, propranolol failed to decrease the rebleeding rate as an adjunct to endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse effects in gastric variceal bleeding patients. A more potent non-selective β-blocker than propranolol might further decrease portal pressure and decrease the rebleeding rate.
Carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. It significantly lowers portal pressure even in propranolol non-responders. However, it is unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal bleeding. The investigators conducted a randomized controlled trial to compare the efficacy of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate injection alone in secondary prophylaxis of gastric 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
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20 to 80 years
- •Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
- •Stable hemodynamic condition for at least 3 days after cyanoacrylate injection
排除标准
- •Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
- •Contraindications to non-selective beta-blockers or cyanoacrylate injection
- •Serum total bilirubin >10 mg/dL
- •Grade III/IV hepatic encephalopathy
- •Hepato-renal syndrome
- •Severe heart failure (NYHA Fc III/IV)
- •Chronic kidney disease under renal replacement therapy
- •Refractory ascites
- •Malignancy other than hepatocellular carcinoma
- •Pregnancy
- •Pacemaker use
- •Refusal to participate
研究组 & 干预措施
Cyanoacrylate injection plus carvedilol
The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
干预措施: carvedilol (Drug)
Cyanoacrylate injection plus carvedilol
The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose.
干预措施: cyanoacrylate (Drug)
Cyanoacrylate injection
The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
干预措施: cyanoacrylate (Drug)
结局指标
主要结局
Rebleeding From Gastric Varices
时间窗: Within 6 years
Rebleeding from gastric varices during the follow-up period
次要结局
- All Cause Mortality or Liver Transplantation(Within 6 years)
- All Upper Gastrointestinal Bleeding(Within 6 years)
- All Adverse Effects(Within 6 years)
研究者
Wen-Chi Chen
MD
Kaohsiung Veterans General Hospital.
