Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding

Phase 3

• Conditions: Hematemesis; Gastrointestinal Hemorrhage
• Interventions: Procedure: gastric lavage; Drug: Erythromycin

• Registration Number: NCT01716572
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.

Detailed Description

The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.

One hundred and twenty-two patients admitted within 12 hours after hematemesis will be randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of examination of the upper gastrointestinal tract by using scales designed by Frossard and Avgerinos .

Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood units transfused, the need of surgery or arteriography, and the mean duration of hospitalization

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• recent hematemesis (<12 hours)

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Exclusion Criteria

• macrolides allergy
• pregnancy or lactation
• treatment with terfenadine, astemizole or cyclosporine
• prior gastrectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gastric lavage	gastric lavage	gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
erythromycin	Erythromycin	administration of 250mgr of erythromycin before the endoscopy

Primary Outcome Measures

Name	Time	Method
Visual quality of endoscopy	The endoscopy will be recorded and subsequently it will be evaluated by two endoscopists unaware of the cleaning strategy. The recording's evaluation will be made within the first 30 days after endoscopy	To assess the visual quality of endoscopy the investigators will use the Avgerinos' score modified by Frossard (Gastroenterology 2002;123:17-23). An score from 0 to 2(0 worst vision, where \< 25% of the surface was visible. 1, 25-75% visible and 2 \>75% visible) was derived from analysis of each area (fundus, body, antrum and bulbus). A score of 6 or greater is considered as a clear stomach, and a score of 5 or lower was considered as a full stomach.

Secondary Outcome Measures

Name	Time	Method
length of endoscopic procedure	within the first 30 days after endoscopy
need for a second-look endoscopy	within the first 30 days after endoscopy	To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
number of adverse events as a measure of safety and tolerability	within the first 30 days after endoscopy
length of hospitalisation	within the first 30 days after endoscopy
need for arteriography or surgery	within the first 30 days after endoscopy
need of blood transfusion	within 30 days after endoscopy

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain