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

Study Overview
=================
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

Official Title
-----------------
Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.

Conditions
-----------------
Gastrointestinal Hemorrhage, Hematemesis

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Procedure: gastric lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recent hematemesis (<12 hours) Exclusion Criteria: macrolides allergy pregnancy or lactation treatment with terfenadine, astemizole or cyclosporine prior gastrectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gastric lavage<br>gastric lavage by nasogastric tube with 1 liter saline before the endoscopy | Procedure: gastric lavage<br>* gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy<br>|
| Active Comparator: erythromycin<br>administration of 250mgr of erythromycin before the endoscopy | Drug: Erythromycin<br>* Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy<br>* Other names: Pantomicina Intravenosa;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual quality of 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for a second-look endoscopy | To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding | within the first 30 days after endoscopy | 
| need of blood transfusion |  | within 30 days after endoscopy | 
| 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 | 
| length of endoscopic procedure |  | within the first 30 days after endoscopy | 
| need for arteriography or surgery |  | within the first 30 days after endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper gastrointestinal bleeding, Endoscopy, Erythromycin, Gastric lavage