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NCT Number: NCT00259220

HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to 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.

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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Jean VERDIER

Bondy, 93140, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hematemesis or melaena
  • No QT enlargement

Exclusion criteria

  • Refusing endoscopy
  • Glasgow < 15

Treatment and study plan

Erythomycin

Drug

erythomycin

gastric lavage alone

Procedure

gastric lavage alone

erythromycine and gastric lavage

Procedure

erythromycine and gastric lavage

Primary outcomes

  1. Endoscopic yield

    Time frame: at the beggining of the study

Secondary outcomes

  1. Rebleeding until D 30, transfusion, gastric tube or erythromycin complications

    Time frame: until 30 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 29, 2005
Registry last updated
Oct 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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