EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Bleeding rate secondary to gastric varices
研究概览
简要总结
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
详细描述
Gastric variceal bleeding is a severe condition associated with a high mortality. Bleeding from varices bleeding will be defined as the occurrence of hematemesis and/or melena requiring >2 U of blood or a decrease of 2 gm/dl of hemoglobin if no blood transfusion is given, with the confirmed endocopic visualization of GOV II and IGV I.
The beta blocker therapy is an effective method for the prevention of the first esophageal variceal bleeding; however, the efficacy in preventing first gastric variceal bleeding is controversial.
The investigators aimed to compare the efficacy in preventing the first gastric variceal bleeding in patients with documented GOV II and IGV I.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Endoscopic performing EUS evaluation on follow-up will be masked to initial patient allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old
- •Writeen informed consent provided.
- •Proven GV (GOV II or IGV I) on esophagogastroduodenoscopy and EUS.
- •Gastric varices with high-risk of bleeding (large diameter, high MELD score, presence of portal hypertensive gastropathy)
- •Patient preference for EUS-guided therapy.
排除标准
- •Under 18 years old.
- •Refuse to sign written informed consent.
- •Pregnancy or nursing.
- •Previous treatment of gastric varices.
- •Non-cirrhotic portal hypertension
- •Concurrent hepato-renal syndrome and/or multi-organ failure.
- •Proven malignancy including hepatocellular carcinoma
- •Platelet count less than 50,000/ml or International Normalized Rate (INR) >
- •Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
- •Esophageal stricture.
- •Uncontrolled coagulopathy.
研究组 & 干预措施
EUS-guided combined therapy
Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.
干预措施: Coils + Cyanoacrylate Group + beta-blocker (Procedure)
Beta Blocker (Propranolol)
o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.
干预措施: beta blocker therapy (Drug)
结局指标
主要结局
Bleeding rate secondary to gastric varices
时间窗: 12 months
Number of patients with melena or hematemesis accompanied by Hemoglobin drop \> 2g/dL
Mortality secondary to gastrointestinal bleeding
时间窗: 12 months
mortality rate
次要结局
- Number of reinterventions(12 months)