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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01716572
Other study ID # ERITRO2011
Secondary ID
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


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
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