Endoscopic Ultrasound (EUS) Guided Cyanoacrylate Injection for Variceal Obturation as Secondary Prophylaxis for Patients at High Risk for Recurrent Gastroesophageal Variceal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rebleeding rate
研究概览
简要总结
Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After successful treatment of the acute bleeding episode, patients who do not receive follow-up treatment to prevent rebleeding were reported to have a rebleeding rate of 60% within 1- 2 years. The presence of liver cancer and/or portal vein thrombosis has been associated with recurrent variceal bleeding. In a study of liver cancer patients in Hong Kong, 7.9% of patients developed at least 1 episode of variceal bleeding over the course of liver cancer.
In patients with portal hypertension from cirrhosis, current guidelines recommend non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial bleeding, and either cyanoacrylate injection for variceal obturation or transjugular intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is unclear whether the above strategies will have the same clinical effect for patients with liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.
Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection for variceal obturation has been described. In a study of patients with gastric variceal bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all patients and 96% of the gastric varices remained obliterated during the follow-up period. To date, there has been no dedicated study to evaluate the role of EUS guided glue injection for prevention of future bleeding in patients at high risk for recurrent variceal bleeding such as those with liver cancer or portal vein thrombosis.
The investigators propose this study to evaluate the feasibility and safety of EUS guided glue injection for follow-up variceal treatment in patients at high risk for recurrent variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.
详细描述
Gastroesophageal variceal bleeding is one of the major complications of cirrhosis and occurs at a rate of 5 to 15% per year. 50% of patients with cirrhosis develop variceal bleeding during their lifetime. Large varix size, presence of red wale signs on endoscopy, and decompensated cirrhosis are predictors of variceal hemorrhage. Current first-line management of acute variceal bleeding includes a combination of vasoactive drug, endoscopic therapy and antibiotic prophylaxis. Despite advances in the management of acute variceal bleeding, the 6-week mortality remains significant at 15 - 20% per episode of variceal bleeding.
In patients who survive the acute variceal bleeding episode but without secondary prophylaxis, the median rebleeding rate is about 60% within 1- 2 years of the index bleeding with a mortality of 33%. The presence of hepatocellular carcinoma (HCC) and/or portal vein thrombosis (PVT) have been associated with recurrent variceal bleeding and worse outcome. In a retrospective study of 2928 HCC patients in Hong Kong, 7.9% of the patients developed at least 1 episode of variceal bleeding over the course of HCC. In cirrhotic patients with PVT but without HCC, variceal bleeding is not an uncommon complication.
In patients with portal hypertension from cirrhosis, current guidelines recommend non-selective beta-blocker, endoscopic band ligation for esophageal varices after initial bleeding, and either cyanoacrylate injection for variceal obturation or transjugular intrahepatic portosystemic shunt for gastric varices after initial bleeding. However, it is unclear whether the above strategies will have the same clinical effect for patients with liver cancer and/or portal vein thrombosis who are at high risk for recurrent bleeding.
Recently, the technique of endoscopic ultrasound (EUS) guided cyanoacrylate (glue) injection for variceal obturation has been described. In a study of patients with gastric variceal bleeding, EUS guided glue injection and coiling was reported to achieve hemostasis in all patients and 96% of the gastric varices remained obliterated during the follow-up period. To date, there has been no dedicated study to evaluate the role of EUS guided glue injection for prevention of future bleeding in patients at high risk for recurrent variceal bleeding such as those with liver cancer or portal vein thrombosis.
The investigators propose this study to evaluate the feasibility and safety of EUS guided glue injection for follow-up variceal treatment in patients at high risk for recurrent variceal bleeding, such as those with liver cancer and/or portal vein thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with hepatocellular carcinoma (liver cancer), and/or portal vein thrombosis, who have presented with gastroesophageal variceal bleeding within 12 weeks
- •Age > 18 years
- •Written informed consent available
排除标准
- •Contraindications for endoscopy due to comorbidities
- •Unable to provide written informed consent
- •Refractory coagulopathy (INR>1.5) or refractory thrombocytopenia (platelets <50,000) despite blood product transfusion
- •Pregnant patients
- •Moribund patients from terminal illnesses
结局指标
主要结局
Rebleeding rate
时间窗: 6 months
Number of participants who undergo EUS guided glue injection and develop rebleeding during the 3-month and 6-month follow up period
次要结局
- bleeding free interval after index procedure(12 months)
- Technical success(At time of procedure)
- procedural complication(12 months)
研究者
Raymond Shing Yan Tang
Clinical Professional Consultant
Chinese University of Hong Kong
