<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/NCT02219568</url>
  </required_header>
  <id_info>
    <org_study_id>Si624/2013</org_study_id>
    <nct_id>NCT02219568</nct_id>
  </id_info>
  <brief_title>Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding</brief_title>
  <official_title>Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy between video capsule endoscopy and CT&#xD;
      enterography in diagnosis of obscure gastrointestinal bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All adult patients with obscure gastrointestinal bleeding will undergo both video capsule&#xD;
      endoscopy and CT enterography. The interval between two tests will be less than 1 month. The&#xD;
      capsule reading gastroenterologist and the CT reading radiologist are blinded to each others'&#xD;
      results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of significant gastrointestinal lesions detected</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>obscure gastrointestinal bleeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CT enterography</intervention_name>
    <description>CT enterography is performed using 64-channel multi-detector row CT scanners (Siemens Sensation 64, Siemens Medical solution, Forchiem, Germany). Prior to the scan, 1500 cc of a neutral oral-enteric contrast material, polyethylene glycol (NIFLEC) is taken by the patient. During the scan, 2cc/kg of intravenous contrast (iohexol, Ominipaque Amersham GE-Health care, Princeton, NJ) is injected at the velocity 5 cc/sec.</description>
    <arm_group_label>obscure gastrointestinal bleeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>video capsule endoscopy</intervention_name>
    <description>Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.</description>
    <arm_group_label>obscure gastrointestinal bleeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who present with passing melena or hematochezia or have iron deficiency&#xD;
             anemia&#xD;
&#xD;
          -  no lesion found on both esophagogastroduodenoscopy and colonoscopy&#xD;
&#xD;
          -  age at least 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to iodinated intravenous contrast&#xD;
&#xD;
          -  chronic kidney disease stage at least 3 patients who do not on regular dialysis&#xD;
&#xD;
          -  suspected small bowel obstruction&#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>Julajak Limsrivilai, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Julajak Limsrivilai</investigator_full_name>
    <investigator_title>Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital</investigator_title>
  </responsible_party>
  <keyword>obscure gastrointestinal bleeding, CT enterography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT02219568
org study id: Si624/2013
nct id: NCT02219568
lead sponsor: 
The purpose of this study is to compare the efficacy between video capsule endoscopy and CT
      enterography in diagnosis of obscure gastrointestinal bleeding.
All adult patients with obscure gastrointestinal bleeding will undergo both video capsule
      endoscopy and CT enterography. The interval between two tests will be less than 1 month. The
      capsule reading gastroenterologist and the CT reading radiologist are blinded to each others'
      results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: number of significant gastrointestinal lesions detected
time frame: up to 1 month
description: Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.
arm group label: obscure gastrointestinal bleeding
arm group type: Experimental
description: Those patients who developed obscure gastrointestinal bleeding either overt or occult bleeding who will then undergo video capsule endoscopy and CT enterography.
intervention type: Procedure
intervention name: CT enterography
description: CT enterography is performed using 64-channel multi-detector row CT scanners (Siemens Sensation 64, Siemens Medical solution, Forchiem, Germany). Prior to the scan, 1500 cc of a neutral oral-enteric contrast material, polyethylene glycol (NIFLEC) is taken by the patient. During the scan, 2cc/kg of intravenous contrast (iohexol, Ominipaque Amersham GE-Health care, Princeton, NJ) is injected at the velocity 5 cc/sec.
arm group label: obscure gastrointestinal bleeding
intervention type: Device
intervention name: video capsule endoscopy
description: Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.
arm group label: obscure gastrointestinal bleeding
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julajak Limsrivilai, M.D.
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Julajak Limsrivilai
investigator title: Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage