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

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: November 28, 2005
Last updated: September 30, 2008
Last verified: March 2007
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.

Condition Intervention Phase
Upper Gastrointestinal Bleeding
Drug: erythomycin
Procedure: gastric lavage alone
Procedure: erythromycine and gastric lavage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Endoscopic yield [ Time Frame: at the beggining of the study ]

Secondary Outcome Measures:
  • Rebleeding until D 30, transfusion, gastric tube or erythromycin complications [ Time Frame: until 30 days ]

Enrollment: 270
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drug
Drug: erythomycin
gastric lavage alone
Procedure: gastric lavage alone
gastric lavage alone
Active Comparator: 3
erythromycine and gastric lavage
Procedure: erythromycine and gastric lavage
erythromycine and gastric lavage

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hematemesis or melaena
  • No QT enlargement

Exclusion Criteria:

  • Refusing endoscopy
  • Glasgow < 15
  Contacts and Locations
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Please refer to this study by its identifier: NCT00259220

Hôpital Jean VERDIER
Bondy, France, 93140
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Dominique PATERON, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Myriem CARRIER, Department Clinical Research of Developpement Identifier: NCT00259220     History of Changes
Other Study ID Numbers: P040427
Study First Received: November 28, 2005
Last Updated: September 30, 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Gastric tube

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 28, 2017