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

Overview

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 Title of Study: “Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2015

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

Interventions

  • Drug: Erythromycin
    • Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
  • Procedure: gastric lavage
    • gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy

Arms, Groups and Cohorts

  • Active Comparator: gastric lavage
    • gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
  • Active Comparator: erythromycin
    • administration of 250mgr of erythromycin before the endoscopy

Clinical Trial Outcome Measures

Primary 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
    • 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 Measures

  • need for a second-look endoscopy
    • Time Frame: within the first 30 days after endoscopy
    • 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
  • number of adverse events as a measure of safety and tolerability
    • Time Frame: within the first 30 days after endoscopy
  • length of hospitalisation
    • Time Frame: within the first 30 days after endoscopy
  • length of endoscopic procedure
    • Time Frame: within the first 30 days after endoscopy
  • need for arteriography or surgery
    • Time Frame: within the first 30 days after endoscopy

Participating in This Clinical Trial

Inclusion Criteria

  • recent hematemesis (<12 hours)

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitari de Bellvitge
  • Collaborator
    • Ministerio de Sanidad, Servicios Sociales e Igualdad
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Antonio Soriano Izquierdo, Physician Doctor – Hospital Universitari de Bellvitge
  • Overall Official(s)
    • Antonio Soriano, M D, Ph D, Principal Investigator, Hospital Universitari de Bellvitge

References

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

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