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临床试验/NCT02504723
NCT02504723已完成4 期

Carvedilol Plus Endoscopic Cyanoacrylate Injection Versus Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Chi Chen

MD

Kaohsiung Veterans General Hospital.

研究点 (1)

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