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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hospital Universitari de Bellvitge.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Dr Antonio Soriano Izquierdo, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01716572
First received: June 28, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Gastrointestinal Hemorrhage
Hematemesis
Drug: Erythromycin
Procedure: gastric lavage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Visual quality of endoscopy [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 30 days after endoscopy ] [ Designated as safety issue: No ]
  • number of adverse events as a measure of safety and tolerability [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: Yes ]
  • length of hospitalisation [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
  • length of endoscopic procedure [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]
  • need for arteriography or surgery [ Time Frame: within the first 30 days after endoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: February 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gastric lavage Procedure: gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Active Comparator: erythromycin Drug: Erythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Other Name: Pantomicina Intravenosa

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716572

Contacts
Contact: Antonio Soriano, M.D. 0034932607234 antoniosoriano@bellvitgehospital.cat

Locations
Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Antonio Soriano, M.D.    0034932607234    antoniosoriano@bellvitgehospital.cat   
Principal Investigator: Antonio Soriano, M.D.         
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
  More Information

Publications:

Responsible Party: Dr Antonio Soriano Izquierdo, Physician Doctor, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01716572     History of Changes
Other Study ID Numbers: ERITRO2011
Study First Received: June 28, 2012
Last Updated: October 25, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Upper gastrointestinal bleeding
Endoscopy
Erythromycin
Gastric lavage

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Hematemesis
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014