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

Catalan Institute of Health

Status and phase: Unknown; Phase 3

Conditions: Gastrointestinal Hemorrhage; Hematemesis

Treatments: Drug: Erythromycin; Procedure: gastric lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01716572

ERITRO2011

Details and patient eligibility

About

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.

Full 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

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• recent hematemesis (<12 hours)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

gastric lavage

Active Comparator group

Description:

gastric lavage by nasogastric tube with 1 liter saline before the endoscopy

Treatment:

Procedure: gastric lavage

erythromycin

Active Comparator group

Description:

administration of 250mgr of erythromycin before the endoscopy

Treatment:

Drug: Erythromycin