Upper Gastrointestinal Bleeding Clinical Trial
Official title:
In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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