Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: gastric lavage gastric lavage by nasogastric tube with 1 liter saline before the endoscopy |
Procedure: gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
|
| Active Comparator: erythromycin administration of 250mgr of erythromycin before the endoscopy |
Drug: Erythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Visual quality of endoscopy [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 Outcome Measures
- need for a second-look endoscopy [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 [within 30 days after endoscopy]
- number of adverse events as a measure of safety and tolerability [within the first 30 days after endoscopy]
- length of hospitalisation [within the first 30 days after endoscopy]
- length of endoscopic procedure [within the first 30 days after endoscopy]
- need for arteriography or surgery [within the first 30 days after endoscopy]
Eligibility Criteria
Criteria
Inclusion Criteria:
- recent hematemesis (<12 hours)
Exclusion Criteria:
-
macrolides allergy
-
pregnancy or lactation
-
treatment with terfenadine, astemizole or cyclosporine
-
prior gastrectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
Sponsors and Collaborators
- Hospital Universitari de Bellvitge
- Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
- Principal Investigator: Antonio Soriano, M D, Ph D, Hospital Universitari de Bellvitge
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- ERITRO2011