Clinical trial NCT01716572: Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding
Official title: Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastrointestinal Hemorrhage
Hematemesis
Keywords: Upper gastrointestinal bleeding
Endoscopy
Erythromycin
Gastric lavage
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2012-10-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* recent hematemesis (\<12 hours)

Exclusion Criteria:

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

Primary outcomes:
measure: Visual quality of endoscopy
timeFrame: 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:
measure: need for a second-look endoscopy
timeFrame: within the first 30 days after endoscopy
measure: need of blood transfusion
timeFrame: within 30 days after endoscopy
measure: number of adverse events as a measure of safety and tolerability
timeFrame: within the first 30 days after endoscopy
measure: length of hospitalisation
timeFrame: within the first 30 days after endoscopy
measure: length of endoscopic procedure
timeFrame: within the first 30 days after endoscopy
measure: need for arteriography or surgery
timeFrame: within the first 30 days after endoscopy
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Antonio Soriano, M D, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.