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

Primary Purpose

Gastrointestinal Hemorrhage, Hematemesis

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Erythromycin
gastric lavage
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Hemorrhage focused on measuring Upper gastrointestinal bleeding, Endoscopy, Erythromycin, Gastric lavage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recent hematemesis (<12 hours)

Exclusion Criteria:

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

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

gastric lavage

erythromycin

Arm Description

gastric lavage by nasogastric tube with 1 liter saline before the endoscopy

administration of 250mgr of erythromycin before the endoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
need of blood transfusion
number of adverse events as a measure of safety and tolerability
length of hospitalisation
length of endoscopic procedure
need for arteriography or surgery

Full Information

First Posted
June 28, 2012
Last Updated
October 7, 2015
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad
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1. Study Identification

Unique Protocol Identification Number
NCT01716572
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage, Hematemesis
Keywords
Upper gastrointestinal bleeding, Endoscopy, Erythromycin, Gastric lavage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gastric lavage
Arm Type
Active Comparator
Arm Description
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
Arm Title
erythromycin
Arm Type
Active Comparator
Arm Description
administration of 250mgr of erythromycin before the endoscopy
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Other Intervention Name(s)
Pantomicina Intravenosa
Intervention Description
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Intervention Type
Procedure
Intervention Name(s)
gastric lavage
Intervention Description
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Primary Outcome Measure Information:
Title
Visual quality of endoscopy
Description
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.
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
Secondary Outcome Measure Information:
Title
need for a second-look endoscopy
Description
To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
Time Frame
within the first 30 days after endoscopy
Title
need of blood transfusion
Time Frame
within 30 days after endoscopy
Title
number of adverse events as a measure of safety and tolerability
Time Frame
within the first 30 days after endoscopy
Title
length of hospitalisation
Time Frame
within the first 30 days after endoscopy
Title
length of endoscopic procedure
Time Frame
within the first 30 days after endoscopy
Title
need for arteriography or surgery
Time Frame
within the first 30 days after endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recent hematemesis (<12 hours) Exclusion Criteria: macrolides allergy pregnancy or lactation treatment with terfenadine, astemizole or cyclosporine prior gastrectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Soriano, M D, Ph D
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12105828
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. Erratum In: Gastroenterology 2002 Dec;123(6):2162.
Results Reference
background
PubMed Identifier
12145593
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.
Results Reference
background
PubMed Identifier
16771939
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.
Results Reference
background
PubMed Identifier
21333385
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.
Results Reference
background
PubMed Identifier
20970794
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.
Results Reference
background
PubMed Identifier
17848180
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.
Results Reference
background
PubMed Identifier
20083829
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.
Results Reference
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Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding

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