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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01716572
• Other study ID #: ERITRO2011
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 28, 2012
• Last updated: October 7, 2015
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• recent hematemesis (<12 hours)

Exclusion Criteria:

• macrolides allergy

• pregnancy or lactation

• treatment with terfenadine, astemizole or cyclosporine

• prior gastrectomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hematemesis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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. — View 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. Erratum in: Gastroenterology 2002 Dec;123(6):2162. — View 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. — View 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. Epub 2007 Sep 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	need for a second-look endoscopy	To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding	within the first 30 days after endoscopy	No
Secondary	need of blood transfusion		within 30 days after endoscopy	No
Secondary	number of adverse events as a measure of safety and tolerability		within the first 30 days after endoscopy	Yes
Secondary	length of hospitalisation		within the first 30 days after endoscopy	No
Secondary	length of endoscopic procedure		within the first 30 days after endoscopy	No
Secondary	need for arteriography or surgery		within the first 30 days after endoscopy	No