Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Hemorrhage Hematemesis	Drug: Erythromycin Procedure: gastric lavage	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding

Drug Information available for: Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin phosphate

U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:

Visual quality of endoscopy [ Time Frame: 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 ] [ Designated as safety issue: No ]
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:

need for a second-look endoscopy [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
need of blood transfusion [ Time Frame: within 30 days after endoscopy ] [ Designated as safety issue: No ]
number of adverse events as a measure of safety and tolerability [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: Yes ]
length of hospitalisation [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
length of endoscopic procedure [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
need for arteriography or surgery [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment:	122
Study Start Date:	February 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: gastric lavage	Procedure: gastric lavage gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Active Comparator: erythromycin	Drug: Erythromycin Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy Other Name: Pantomicina Intravenosa

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

recent hematemesis (<12 hours)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716572

Contacts

Contact: Antonio Soriano, M.D.

0034932607234

antoniosoriano@bellvitgehospital.cat

Locations

Spain
Hospital Universitari de Bellvitge	Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Antonio Soriano, M.D. 0034932607234 antoniosoriano@bellvitgehospital.cat
Principal Investigator: Antonio Soriano, M.D.

Sponsors and Collaborators

Hospital Universitari de Bellvitge

Ministerio de Sanidad, Politica Social e Igualdad

Investigators

Principal Investigator:

Antonio Soriano, M D, Ph D

Hospital Universitari de Bellvitge

More Information

Publications:

Frossard JL, Spahr L, Queneau PE, Giostra E, Burckhardt B, Ory G, De Saussure P, Armenian B, De Peyer R, Hadengue A. Erythromycin intravenous bolus infusion in acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Gastroenterology. 2002 Jul;123(1):17-23. Erratum in: Gastroenterology 2002 Dec;123(6):2162.

Coffin B, Pocard M, Panis Y, Riche F, Lainé MJ, Bitoun A, Lémann M, Bouhnik Y, Valleur P; Groupe des endoscopistes de garde á l'AP-HP. Erythromycin improves the quality of EGD in patients with acute upper GI bleeding: a randomized controlled study. Gastrointest Endosc. 2002 Aug;56(2):174-9.

Carbonell N, Pauwels A, Serfaty L, Boelle PY, Becquemont L, Poupon R. Erythromycin infusion prior to endoscopy for acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Am J Gastroenterol. 2006 Jun;101(6):1211-5.

Pateron D, Vicaut E, Debuc E, Sahraoui K, Carbonell N, Bobbia X, Thabut D, Adnet F, Nahon P, Amathieu R, Aout M, Javaud N, Ray P, Trinchet JC; HDUPE Collaborative Study Group. Erythromycin infusion or gastric lavage for upper gastrointestinal bleeding: a multicenter randomized controlled trial. Ann Emerg Med. 2011 Jun;57(6):582-9. Epub 2011 Feb 17.

Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45.

Winstead NS, Wilcox CM. Erythromycin prior to endoscopy for acute upper gastrointestinal haemorrhage: a cost-effectiveness analysis. Aliment Pharmacol Ther. 2007 Nov 15;26(10):1371-7. Epub 2007 Sep 10. Review.

Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13.

Responsible Party:	Dr Antonio Soriano Izquierdo, Physician Doctor, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:	NCT01716572 History of Changes
Other Study ID Numbers:	ERITRO2011
Study First Received:	June 28, 2012
Last Updated:	October 25, 2012
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:

Upper gastrointestinal bleeding
Endoscopy
Erythromycin
Gastric lavage

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage
Hematemesis
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Erythromycin stearate
Erythromycin

Erythromycin Estolate
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013