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

NCT01716572 | Unknown Phase 3

• 1 other identifier: ERITRO2011
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hemorrhage; Hematemesis

Keywords

Upper gastrointestinal bleeding; Endoscopy; Erythromycin; Gastric lavage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• need for a second-look endoscopy

  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

Study Arms (2)

gastric lavage

ACTIVE COMPARATOR

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

Procedure: gastric lavage

erythromycin

ACTIVE COMPARATOR

administration of 250mgr of erythromycin before the endoscopy

Drug: Erythromycin

Interventions

Erythromycin DRUG

Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy

Also known as: Pantomicina Intravenosa

erythromycin

gastric lavage PROCEDURE

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

gastric lavage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recent hematemesis (\<12 hours)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (7)

• 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. doi: 10.1053/gast.2002.34230.

  PMID: 12105828 BACKGROUND

• Coffin B, Pocard M, Panis Y, Riche F, Laine MJ, Bitoun A, Lemann M, Bouhnik Y, Valleur P; Groupe des endoscopistes de garde a 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. doi: 10.1016/s0016-5107(02)70174-0.

  PMID: 12145593 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2006.00582.x.

  PMID: 16771939 BACKGROUND

• 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. doi: 10.1016/j.annemergmed.2011.01.001. Epub 2011 Feb 17.

  PMID: 21333385 BACKGROUND

• 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. doi: 10.1016/j.gie.2010.08.011.

  PMID: 20970794 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.2007.03516.x. Epub 2007 Sep 10.

  PMID: 17848180 BACKGROUND

• 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. doi: 10.7326/0003-4819-152-2-201001190-00009.

  PMID: 20083829 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hematemesis

Interventions

Erythromycin; Gastric Lavage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Antonio Soriano, M D, Ph D

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Doctor

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: October 30, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

ES (1)