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临床试验/NCT00259220
NCT00259220已完成3 期

In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
270
试验地点
1
主要终点
Endoscopic yield

研究概览

简要总结

Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.

详细描述

Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration.

This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hematemesis or melaena
  • No QT enlargement

排除标准

  • Refusing endoscopy
  • Glasgow < 15

研究组 & 干预措施

drug

Experimental

erythromycine

干预措施: erythomycin (Drug)

2

Other

gastric lavage alone

干预措施: gastric lavage alone (Procedure)

3

Active Comparator

erythromycine and gastric lavage

干预措施: erythromycine and gastric lavage (Procedure)

结局指标

主要结局

Endoscopic yield

时间窗: at the beggining of the study

次要结局

  • Rebleeding until D 30, transfusion, gastric tube or erythromycin complications(until 30 days)

研究者

申办方类型
Other

研究点 (1)

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