Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding
NCT ID: NCT01716572
Last Updated: 2015-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
122 participants
INTERVENTIONAL
2012-02-29
2015-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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gastric lavage
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
erythromycin
administration of 250mgr of erythromycin before the endoscopy
Erythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Interventions
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Erythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy or lactation
* treatment with terfenadine, astemizole or cyclosporine
* prior gastrectomy
18 Years
ALL
No
Sponsors
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Ministerio de Sanidad, Servicios Sociales e Igualdad
OTHER_GOV
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Dr Antonio Soriano Izquierdo
Physician Doctor
Principal Investigators
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Antonio Soriano, M D, Ph D
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ERITRO2011
Identifier Type: -
Identifier Source: org_study_id
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