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临床试验/NCT01287702
NCT01287702Unknown4 期

The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices

E-DA Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
120
试验地点
1
主要终点
Success rate of initial hemostasis

研究概览

简要总结

The impact of feeding after endoscopic treatment of gastroesophageal varices has never been investigated. It is still unknown whether early feeding may increase early rebleeding in patients with acute esophageal variceal bleeding treated with EVL. It is customary for clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe approach to watch against early rebleeding. However, many patients would be fasting for a longer time and nutrition may be impaired, possibly resulting in aggravation of ascites. Thus, the investigators conduct a controlled study to evaluate whether early feeding have a bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric varices.

详细描述

Acute esophageal variceal hemorrhage is a dreadful complication of portal hypertension. Its management evolved rapidly in recent years. Traditional managements include vasoconstrictor and balloon tamponade. Vasoconstrictors have been shown to control approximately 80% of bleeding episodes, are generally used as a first line therapy. Following the use of vasoconstrictor, endoscopic therapy is often employed to arrest the bleeding varices as well as preventing early rebleeding. Meta-analysis showed that the combination of vasoconstrictor and endoscopic therapy is superior to endoscopic therapy alone in the control of acute esophageal variceal hemorrhage. Our previous study showed that endoscopic variceal ligation (EVL) is superior to Endoscopic injection sclerotherapy (EIS) in the control of active variceal hemorrhage. It is thus recommended that EVL is the first enscopic treatment of choice for acute esophageal variceal bleeding. Moreover, apart from the control of acute variceal bleeding, prophylactic antibiotics has been proven to be helpful in the prevention of bacterial infection as well as preventing early variceal bleeding. With the advent of new treatment modalities and measures taken to approach patients with acute esophageal variceal bleeding, the mortality of acute esophageal variceal bleeding is significantly reduced in recent years.

On the other hand, early rebleeding due to ligation-induced ulcer may be encountered. The impact of feeding after endoscopic treatment of gastroesophageal varices has never been investigated. It is still unknown whether early feeding may increase early rebleeding in patients with acute esophageal variceal bleeding treated with EVL. It is customary for clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe approach to watch against early rebleeding. However, many patients would be fasting for a longer time and nutrition may be impaired, possibly resulting in aggravation of ascites. Thus, we conduct a controlled study to evaluate whether early feeding have a bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric varices.

Methods of treatment:

Enrolled Criteria:

  1. The etiology of portal hypertension is cirrhosis.
  2. Age ranges between 20-80 y/o.
  3. Patients presenting with acute gastroesophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: 1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or 2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding). Gastric variceal bleeding is defined as active spurting from a gastric varix or presence of red spots on a gastric varix.
  4. EVL is performed after confirmation of acute esophageal variceal bleeding. Histoacryl injection is performed if acute gastric variceal bleeding is diagnosed. Bleeding is arrested on the spot.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •The etiology of portal hypertension is cirrhosis.
  • •Age ranges between 20-80 y/o.
  • •Patients presenting with acute gastroesophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: 1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or 2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding). Gastric variceal bleeding is defined as active spurting from a gastric varix or presence of red spots on a gastric varix.
  • •EVL is performed after confirmation of acute esophageal variceal bleeding. Histoacryl injection is performed if acute gastric variceal bleeding is diagnosed. Bleeding is arrested on the spot.

排除标准

  • •association with severe systemic illness, such as sepsis, COPD, uremia, HCC, > BCLC stage B
  • •failure in the control of bleeding by emergency endoscopic treatment.
  • •moribund patients, died within 12 hours of enrollment
  • •Uncooperative
  • •Ever received EIS, EVL within one month prior to index bleeding
  • •Child-Pugh's scores > 13
  • •Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites

研究组 & 干预措施

Early feeding

Experimental

patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL

干预措施: Early feeding (Dietary Supplement)

Dealyed feeding

Active Comparator

patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.

干预措施: Delayed feeding (Dietary Supplement)

Dealyed feeding

Active Comparator

patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.

干预措施: Dealyed feeding (Dietary Supplement)

结局指标

主要结局

Success rate of initial hemostasis

时间窗: 48 hours

hemostasis for 48 hours after ligation

very early rebleeding rate

时间窗: 48- 120 hours

rebleeding during this period

ulcer bleeding rate

时间窗: 14 days

14 days after ligation of varices

次要结局

  • The amount of blood transfuion and mortality(14 days)

研究者

发起方
E-DA Hospital
申办方类型
Other

研究点 (1)

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