<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/NCT04408872</url>
  </required_header>
  <id_info>
    <org_study_id>2021-9005</org_study_id>
    <nct_id>NCT04408872</nct_id>
  </id_info>
  <brief_title>EUS vs EGD in Emergency Room Patients Referred for EGD</brief_title>
  <acronym>EUSvsEGD</acronym>
  <official_title>A Pilot Study to Assess the Potential Value of Adding Endoscopic Ultrasound (EUS) to Esophago-gastro-duodenoscopy (EGD) in Emergency Room Patients Referred for EGD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many&#xD;
      possible causes for their symptoms. These patients inevitably undergo further testing if EGD&#xD;
      is inconclusive, which adds costs and prolongs emergency room length of stay (LOS).EUS has&#xD;
      traditionally been used after EGD for a myriad of reasons that no longer apply. The&#xD;
      investigators therefore propose a prospective pilot study to determine whether adding primary&#xD;
      EUS to EGD can reduce LOS and resource utilisation in emergency room patients referred for&#xD;
      EGD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many&#xD;
      possible causes for their symptoms. These inevitably undergo further testing if EGD is&#xD;
      inconclusive, which adds costs and inevitably prolongs emergency room length of stay (LOS).&#xD;
&#xD;
      Endoscopic ultrasound (EUS) combines EGD with high-resolution ultrasound imaging of pancreas,&#xD;
      liver and biliary system and is the best test to diagnose bile duct stones, early chronic&#xD;
      pancreatitis, and small [&lt;2cm] pancreatic cancers (all of which cannot be seen by regular&#xD;
      ultrasound or CT scanning or MRI, yet are included in the differential diagnosis of&#xD;
      EGD-negative abdominal pain).&#xD;
&#xD;
      EUS has traditionally been used after EGD, due to lack of availability, increased cost, and&#xD;
      to increased risk due to larger scope diameter. However, the latest generation of EUS scopes&#xD;
      have the same outer diameter as conventional gastroscopes, there is much wider availability&#xD;
      of EUS in university and community hospital settings, and the cost per procedure is lower,&#xD;
      due to increased procedural numbers and reduced maintenance costs.&#xD;
&#xD;
      In experienced hands, diagnostic EUS is now as safe and as accurate as EGD for diagnosing&#xD;
      mucosal pathology and takes approximately 1 minute longer.(1; 2) Previously published work by&#xD;
      our group suggests that EUS may reduce resource consumption in patients with unexplained&#xD;
      abdominal pain.(3) The investigators also showed that in refractory dyspepsia with normal EGD&#xD;
      and CT, EUS identified signs of occult chronic pancreatitis in up to 20% of cases.(4) More&#xD;
      recently, EUS was found to identify previously undiagnosed, potential causes of unexplained&#xD;
      abdominal pain in up to 9% of patients, or at least provides the same, if not more&#xD;
      information than EGD and abdominal US alone.(2; 5; 6)&#xD;
&#xD;
      There are no previous studies that have prospectively compared the yield of EGD and PEUS in&#xD;
      emergency room patients. The investigators hypothesize that adding EUS to EGD (&quot;primary EUS&quot;&#xD;
      [PEUS]) can safely and more efficiently diagnose or exclude significant gastro-intestinal and&#xD;
      pancreatico-biliary pathology in emergency room patients in whom EGD has been requested. The&#xD;
      investigators therefore propose a prospective pilot study to perform a preliminary analysis&#xD;
      of the potential impact of PEUS on the ability to make an early GI diagnosis (EGID), length&#xD;
      of stay (LOS) and resource utilisation in emergency room patients referred for EGD. If there&#xD;
      is sufficient evidence of a clinically useful impact, an appropriately powered study to&#xD;
      determine whether PEUS is clinically superior to EGD with respect to these variables will be&#xD;
      performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not approved by the institution's scientific committee.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This is an open-label two-arm, single center, superiority trial with 1:1 allocation ratio between EUS and standard intervention EGD.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay (LOS) at the emergency room</measure>
    <time_frame>48 hours</time_frame>
    <description>The primary outcome will be time (hours) to discharge, or admission (for a GI diagnosis) after receipt of the endoscopy (EGD or EUS) report by the consulting gastroenterologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of subjects who need to undergo both procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alternate procedures undergone during emergency room stay</measure>
    <time_frame>48 hours</time_frame>
    <description>Number of subsequent imaging procedures other than endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications during emergency room stay</measure>
    <time_frame>96 hours</time_frame>
    <description>Defined as any event that prolongs hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>EGD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Esophago-gastro-duodenoscopy (EGD)</intervention_name>
    <description>EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.</description>
    <arm_group_label>EGD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Endoscopic ultrasound (EUS)</intervention_name>
    <description>EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.</description>
    <arm_group_label>EUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. EGD requested by the consulting gastroenterologist&#xD;
&#xD;
          2. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of hemodynamic instability and/or ongoing active GI bleeding.&#xD;
&#xD;
          2. Any suspicion of obstruction distal to the angle of Treitz.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ANAND SAHAI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Recherche du Centre Hospitalier de l'Université de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche du Centre hospitalier de l'université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</investigator_affiliation>
    <investigator_full_name>A Sahai</investigator_full_name>
    <investigator_title>Gastroenterologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04408872
org study id: 2021-9005
nct id: NCT04408872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many
      possible causes for their symptoms. These patients inevitably undergo further testing if EGD
      is inconclusive, which adds costs and prolongs emergency room length of stay (LOS).EUS has
      traditionally been used after EGD for a myriad of reasons that no longer apply. The
      investigators therefore propose a prospective pilot study to determine whether adding primary
      EUS to EGD can reduce LOS and resource utilisation in emergency room patients referred for
      EGD.
Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many
      possible causes for their symptoms. These inevitably undergo further testing if EGD is
      inconclusive, which adds costs and inevitably prolongs emergency room length of stay (LOS).

      Endoscopic ultrasound (EUS) combines EGD with high-resolution ultrasound imaging of pancreas,
      liver and biliary system and is the best test to diagnose bile duct stones, early chronic
      pancreatitis, and small [<2cm] pancreatic cancers (all of which cannot be seen by regular
      ultrasound or CT scanning or MRI, yet are included in the differential diagnosis of
      EGD-negative abdominal pain).

      EUS has traditionally been used after EGD, due to lack of availability, increased cost, and
      to increased risk due to larger scope diameter. However, the latest generation of EUS scopes
      have the same outer diameter as conventional gastroscopes, there is much wider availability
      of EUS in university and community hospital settings, and the cost per procedure is lower,
      due to increased procedural numbers and reduced maintenance costs.

      In experienced hands, diagnostic EUS is now as safe and as accurate as EGD for diagnosing
      mucosal pathology and takes approximately 1 minute longer.(1; 2) Previously published work by
      our group suggests that EUS may reduce resource consumption in patients with unexplained
      abdominal pain.(3) The investigators also showed that in refractory dyspepsia with normal EGD
      and CT, EUS identified signs of occult chronic pancreatitis in up to 20% of cases.(4) More
      recently, EUS was found to identify previously undiagnosed, potential causes of unexplained
      abdominal pain in up to 9% of patients, or at least provides the same, if not more
      information than EGD and abdominal US alone.(2; 5; 6)

      There are no previous studies that have prospectively compared the yield of EGD and PEUS in
      emergency room patients. The investigators hypothesize that adding EUS to EGD ("primary EUS"
      [PEUS]) can safely and more efficiently diagnose or exclude significant gastro-intestinal and
      pancreatico-biliary pathology in emergency room patients in whom EGD has been requested. The
      investigators therefore propose a prospective pilot study to perform a preliminary analysis
      of the potential impact of PEUS on the ability to make an early GI diagnosis (EGID), length
      of stay (LOS) and resource utilisation in emergency room patients referred for EGD. If there
      is sufficient evidence of a clinically useful impact, an appropriately powered study to
      determine whether PEUS is clinically superior to EGD with respect to these variables will be
      performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is an open-label two-arm, single center, superiority trial with 1:1 allocation ratio between EUS and standard intervention EGD.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Length of stay (LOS) at the emergency room
time frame: 48 hours
description: The primary outcome will be time (hours) to discharge, or admission (for a GI diagnosis) after receipt of the endoscopy (EGD or EUS) report by the consulting gastroenterologist.
measure: Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)
time frame: 48 hours
description: Number of subjects who need to undergo both procedures
measure: Alternate procedures undergone during emergency room stay
time frame: 48 hours
description: Number of subsequent imaging procedures other than endoscopy
measure: Complications during emergency room stay
time frame: 96 hours
description: Defined as any event that prolongs hospital stay
arm group label: EGD
arm group type: Active Comparator
description: SUBJECT WILL UNDERGO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)
arm group label: EUS
arm group type: Experimental
description: SUBJECT WILL UNDERGO ENDOSCOPIC ULTRASOUND (EUS)
intervention type: Diagnostic Test
intervention name: Esophago-gastro-duodenoscopy (EGD)
description: EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.
arm group label: EGD
intervention type: Diagnostic Test
intervention name: Endoscopic ultrasound (EUS)
description: EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.
arm group label: EUS
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ANAND SAHAI
role: Principal Investigator
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
investigator full name: A Sahai
investigator title: Gastroenterologist
mesh term: Emergencies
mesh term: Abdominal Pain
sharing ipd: No