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

September 30, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Hôpital Jean Verdier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hematemesis or melaena
  • No QT enlargement

Exclusion Criteria:

  • Refusing endoscopy
  • Glasgow < 15

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug
erythromycine
Drug: erythomycin
erythomycin
Other: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic yield
Time Frame: at the beggining of the study
at the beggining of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications
Time Frame: until 30 days
until 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Dominique PATERON, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040427
  • AOM04093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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