A Randomized Controlled Trial of Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Rebleeding
研究概览
简要总结
Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. So far the optimal treatment interval remained unknown. The investigators hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention of esophageal variceal rebleeding in cirrhotic patients.
详细描述
Esophageal varices are the most important portosystemic collaterals owing to their rupture results in variceal hemorrhage, which is a devastating event of portal hypertension. Cirrhotic patients surviving a first episode of variceal rupture have a risk of over 60% of suffering from recurrent bleeding within 1 year and mortality from each rebleeding episode is about 20%. Except for patients with a terminal illness, the secondary preventive measures are required to reduce variceal rebleeding to improve patient survival and clinical outcome. Endoscopic and pharmacological therapies are 2 main methods of intervention used to achieve the treatment goals. Endoscopic therapy contains endoscopic injection sclerotherapy (EIS) or endoscopic variceal ligation (EVL), which would obliterate varices by causing thrombosis and fibrosis formation. However, EVL has currently replaced EIS as the endoscopic therapy of choice because it is safer, more effective, and has lower morbidity rate.
Many experts and scholars suggest to repeat EVL every 1-2 weeks until obliteration of esophageal varices to prevent variceal rebleeding, whereas, there are insufficient data to support the concept that EVL at intervals of 1-2 week is appropriate. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. A randomized controlled trial from Japan showed that EVL performed at a bimonthly interval obtained a higher variceal obliteration rate, lower variceal recurrence rate and fewer additional treatments. Bimonthly EVL in the secondary prophylaxis of variceal hemorrhage may be theoretically improper because post-EVL variceal rebleeding could only be significantly reduced in whom variceal obliteration was achieved within a short treatment course. The other retrospective investigation from the United States demonstrated the principal technical aspects of EVL in the prevention of variceal rebleeding, suggesting the benefit of intersession intervals > 3 weeks compared with intervals < 3 weeks.
This randomized controlled study was undertaken to compare the effectiveness and safety of EVL with two different intersession intervals (bimonthly vs. biweekly). In addition, the risk factors that were associated with variceal rebleeding and mortality were analyzed.
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
- Single (Outcomes Assessor)
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
- •active or recent hemorrhage from esophageal varices;
- •portal hypertension caused by cirrhosis
排除标准
- •age > 80 or <20 years old
- •association with hepatocellular carcinoma or other neoplasms;
- •association with cerebral vascular accident, uremia, acute coronary syndrome or other severe illnesses;
- •history of gastric variceal bleeding;
- •a history of undergoing EIS, EVL, cyanoacrylate injection or prior use of beta blocker;
- •a history of prior shunt operation or transjugular intrahepatic portosystemic stent shunt (TIPS);
- •deep jaundice (serum bilirubin > 10 mg/dL);
- •encephalopathy equal to or greater than stage II;
- •failure in control of index variceal bleeding;
- •death within 48 h of admission; or
- •refusal to participate in the trial.
结局指标
主要结局
Rebleeding
时间窗: From date of randomization until the date of first documented rebleeding, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
Rebleeding from esophageal varices was defined as the presence of hematemesis, melena or both and the bleeding source was identified to be esophageal varices by an emergency endoscopy. Only those who had a clinically significant bleeding, including hematemesis/melena, \> 100 ml of fresh blood drained from nasogastric tube, decrease 3 g hemoglobin if no transfusion is given and transfusion requirement \> 2 units of blood in the first 24 hours of admission, were considered rebleeding from portal hypertensive sources.
次要结局
- Variceal recurrence(From date of variceal obliteration until the date of first documented variceal recurrence, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months)
- All-cause death(From date of randomization until the date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months)
研究者
Huay-Min Wang
Department of Internal Medicine, Division of Gastroenterology, Kaohsiung Veterans General Hospital, Kaohsiung
Kaohsiung Veterans General Hospital.