<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716572</url>
  </required_header>
  <id_info>
    <org_study_id>ERITRO2011</org_study_id>
    <nct_id>NCT01716572</nct_id>
  </id_info>
  <brief_title>Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding</brief_title>
  <official_title>Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Sanidad, Servicios Sociales e Igualdad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers will investigate whether erythromycin infusion is better than gastric lavage&#xD;
      prior to emergency endoscopy to improve the quality of examination in patients with upper&#xD;
      gastrointestinal bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The researchers will investigate whether erythromycin infusion is better than gastric lavage&#xD;
      prior to emergency endoscopy to improve the quality of examination in patients with upper&#xD;
      gastrointestinal bleeding.&#xD;
&#xD;
      One hundred and twenty-two patients admitted within 12 hours after hematemesis will be&#xD;
      randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube&#xD;
      prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video&#xD;
      Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of&#xD;
      examination of the upper gastrointestinal tract by using scales designed by Frossard and&#xD;
      Avgerinos .&#xD;
&#xD;
      Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood&#xD;
      units transfused, the need of surgery or arteriography, and the mean duration of&#xD;
      hospitalization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual quality of endoscopy</measure>
    <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</time_frame>
    <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 &lt; 25% of the surface was visible. 1, 25-75% visible and 2 &gt;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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>need for a second-look endoscopy</measure>
    <time_frame>within the first 30 days after endoscopy</time_frame>
    <description>To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need of blood transfusion</measure>
    <time_frame>within 30 days after endoscopy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of adverse events as a measure of safety and tolerability</measure>
    <time_frame>within the first 30 days after endoscopy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospitalisation</measure>
    <time_frame>within the first 30 days after endoscopy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of endoscopic procedure</measure>
    <time_frame>within the first 30 days after endoscopy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for arteriography or surgery</measure>
    <time_frame>within the first 30 days after endoscopy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Gastrointestinal Hemorrhage</condition>
  <condition>Hematemesis</condition>
  <arm_group>
    <arm_group_label>gastric lavage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gastric lavage by nasogastric tube with 1 liter saline before the endoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>erythromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administration of 250mgr of erythromycin before the endoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythromycin</intervention_name>
    <description>Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy</description>
    <arm_group_label>erythromycin</arm_group_label>
    <other_name>Pantomicina Intravenosa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastric lavage</intervention_name>
    <description>gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy</description>
    <arm_group_label>gastric lavage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  recent hematemesis (&lt;12 hours)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  macrolides allergy&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  treatment with terfenadine, astemizole or cyclosporine&#xD;
&#xD;
          -  prior gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Soriano, M D, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari de Bellvitge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>12105828</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12145593</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16771939</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21333385</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20970794</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17848180</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20083829</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 7, 2015</last_update_submitted>
  <last_update_submitted_qc>October 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Dr Antonio Soriano Izquierdo</investigator_full_name>
    <investigator_title>Physician Doctor</investigator_title>
  </responsible_party>
  <keyword>Upper gastrointestinal bleeding</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Erythromycin</keyword>
  <keyword>Gastric lavage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hematemesis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythromycin</mesh_term>
    <mesh_term>Erythromycin Estolate</mesh_term>
    <mesh_term>Erythromycin Ethylsuccinate</mesh_term>
    <mesh_term>Erythromycin stearate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716572
org study id: ERITRO2011
nct id: NCT01716572
lead sponsor: 
collaborator: 
has dmc: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 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
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.
measure: need for a second-look endoscopy
time frame: within the first 30 days after endoscopy
description: To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
measure: need of blood transfusion
time frame: within 30 days after endoscopy
measure: number of adverse events as a measure of safety and tolerability
time frame: within the first 30 days after endoscopy
measure: length of hospitalisation
time frame: within the first 30 days after endoscopy
measure: length of endoscopic procedure
time frame: within the first 30 days after endoscopy
measure: need for arteriography or surgery
time frame: within the first 30 days after endoscopy
arm group label: gastric lavage
arm group type: Active Comparator
description: gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
arm group label: erythromycin
arm group type: Active Comparator
description: administration of 250mgr of erythromycin before the endoscopy
intervention type: Drug
intervention name: Erythromycin
description: Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
arm group label: erythromycin
other name: Pantomicina Intravenosa
intervention type: Procedure
intervention name: gastric lavage
description: gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
arm group label: gastric lavage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Soriano, M D, Ph D
role: Principal Investigator
affiliation: Hospital Universitari de Bellvitge
facility: 
country: Spain
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.
PMID: 12105828
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.
PMID: 12145593
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.
PMID: 16771939
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.
PMID: 21333385
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.
PMID: 20970794
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.
PMID: 17848180
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.
PMID: 20083829
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Dr Antonio Soriano Izquierdo
investigator title: Physician Doctor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hematemesis
mesh term: Hemorrhage
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate