<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/NCT03243240</url>
  </required_header>
  <id_info>
    <org_study_id>CT git bleeding</org_study_id>
    <nct_id>NCT03243240</nct_id>
  </id_info>
  <brief_title>Computed Tomography in Gastrointestinal Bleeding</brief_title>
  <official_title>Role of Triphasic Computed Tomography Imaging in the Detection of Acute Non-variceal Gastrointestinal Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Gastrointestinal bleeding represents a serious clinical problem and a common cause of&#xD;
      hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4%&#xD;
      for lower Gastrointestinal bleeding requires a multidisciplinary approach involving&#xD;
      gastroenterologists, endoscopists, surgeons and radiologists.&#xD;
&#xD;
      Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures.&#xD;
      However, the persistence of bleeding represents a diagnostic challenge to locate the site of&#xD;
      bleeding especially in severe bleeding and to determine, if possible its cause. This will&#xD;
      allow to select the most appropriate therapeutic approach in order to reduce the morbidity&#xD;
      and mortality, the length of hospitalisation and the transfusion requirements.&#xD;
&#xD;
      Current diagnostic algorithms vary widely from institution to institution and from clinician&#xD;
      to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include&#xD;
      endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector&#xD;
      computed tomography imaging.&#xD;
&#xD;
      In recent years, Multidetector computed tomography has emerged as a promising technology to&#xD;
      evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its&#xD;
      use in any emergent situation. In addition, today's high-speed, narrow collimation&#xD;
      multi-detector technology allows a large coverage area with minimal motion artifacts, with&#xD;
      the ability to capture both arterial and venous phase with ease. Multidetector computed&#xD;
      tomography is being increasingly used as this is a widely available, non-invasive and fast&#xD;
      diagnostic technique that allows for visualisation of the entire intestinal tract and its&#xD;
      lesions, the identification of vascularity and possible vascular abnormalities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study.&#xD;
&#xD;
      To maximise detection capabilities, it is crucial that Computed tomography angiography should&#xD;
      begin as soon as possible while the patient is actively bleeding. Patients with active&#xD;
      Gastrointestinal bleeding are assigned to intensive care units, and patients in shock are&#xD;
      promptly resuscitated. Intensive care unit physicians provide appropriate monitoring for&#xD;
      hemodynamically unstable patients undergoing Multidetector computed tomography angiography.&#xD;
      Multidetector computed tomography angiography should be performed without prior oral&#xD;
      administration of water or contrast material. Active contrast material extravasation within&#xD;
      the bowel lumen is obscured by oral contrast material, leading to false-negative results.&#xD;
&#xD;
      Data acquisition: Investigators will perform Multidetector computed tomography angiography&#xD;
      with 16- Multislice computed tomography scanner, medical system bright speed. The protocol&#xD;
      will include non-enhanced scanning then perform a triphasic angiography that includes&#xD;
      arterial, portal and venous phases to detect acute Gastrointestinal bleeding.&#xD;
&#xD;
      Images will be acquired with the following parameters slice thickness 5mm for the unenhanced&#xD;
      phase and 1.25mm for the arterial phase and Porto-venous phases, pitch 1.375, 300 Miliambiar,&#xD;
      120kilovolt and rotation time 0.7 seconds.&#xD;
&#xD;
      Images acquired are reconstructed for coronal, sagittal, Volume Rendering and Maximum&#xD;
      Intensity Projection images. A similar protocol may be used with a 64-Multislice computed&#xD;
      tomography scanner.&#xD;
&#xD;
      A dose of 1-2 ml/kg body weight of concentration 370mg/ml non-ionized contrast media will be&#xD;
      administered at a rate of 4ml/sec, with an upper limit of 150ml. Venous access is an&#xD;
      antecubital vein with a 14 or at least 18G cannula. The scan delay time for the arterial&#xD;
      phase images is obtained by using bolus tracking with a circular region of interest&#xD;
      positioned in the abdominal aorta and a predefined 90-housenfield unit bolus-trigger&#xD;
      threshold to the start of automatic scanning. The coverage from just above the diaphragm to&#xD;
      the Ischial tuberosities including the rectum in all cases.&#xD;
&#xD;
      Study interpretation post processing will be performed with a 4.6 version workstation. All&#xD;
      studies are reviewed in the axial plane and with multiplanar reformation images. Real-time&#xD;
      maximum-intensity projection images facilitate rapid study interpretation for optimal case&#xD;
      management.&#xD;
&#xD;
      The radiologist will try to get the following information:&#xD;
&#xD;
        -  presence or absence of bleeding.&#xD;
&#xD;
        -  localise the site of bleeding.&#xD;
&#xD;
        -  detect the cause of bleeding: tumour, Arteriovenous malformations….. The confirmation of&#xD;
           the triphasic Multislice computed tomography results will be done by angiographic&#xD;
           intervention and embolization of bleeding vessel&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Role of triphasic computed tomography imaging in detection of acute non variceal gastrointestinal tract bleeding</measure>
    <time_frame>one year</time_frame>
    <description>Number of 30 patients with acute gastrointestinal bleeding will undergo multislice computed tomography angiography with 16 multislice computed tomography scanner with dose 1-2ml/kg body weight contrast media and the study will be revised to detect the contrast extravasation which means active bleeding, and will detect the cause of bleeding such as tumor, aneurysm, arteriovenous malformation....and confirmation of these results will be done by angiographic intervention and embolization of the bleeding vessel</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gastrointestinal Bleeding</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>mutlidetector computed tomography</intervention_name>
    <description>Multidetector computed tomography angiography with 16- MSCT scanner, medical system bright speed. Our protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute gastrointestinal bleeding.&#xD;
Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and porto-venous phases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study.&#xD;
&#xD;
        This study will be performed in Radio diagnostic department in Assiut University Hospital.&#xD;
&#xD;
        We will perform multi detector computed tomography angiography with 16 or 64 multi slice&#xD;
        computed tomography scanner.&#xD;
&#xD;
        our protocol will include non enhanced scanning then perform triphasic angiography that&#xD;
        include arterial , portal and venous phases to detect gastrointestinal bleeding.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with unexplained non variceal gastrointestinal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with impaired renal functions or terminal liver failure. pregnancy. patients&#xD;
             known to be sensitive to contrast media. cases diagnosed endoscopically as variceal&#xD;
             bleeding.&#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>Ghada Abdelsabour, resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hany Mohammed, Professor</last_name>
    <phone>01119159500</phone>
    <email>Hany.rad@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omran Khodary, Lecturer</last_name>
    <phone>01117298484</phone>
    <email>Omranshow@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Geffroy Y, Rodallec MH, Boulay-Coletta I, Julles MC, Ridereau-Zins C, Zins M. Multidetector CT angiography in acute gastrointestinal bleeding: why, when, and how. Radiographics. 2011 May-Jun;31(3):E35-46. doi: 10.1148/rg.313105206. Erratum In: Radiographics. 2011 Nov-Dec;31(7):2114. Fulles, Marie-Christine [corrected to Julles, Marie-Christine]. Radiographics. 2011 Sep-Oct;31(5):1496.</citation>
    <PMID>21721196</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ghada abdelsabour</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <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/NCT03243240
org study id: CT git bleeding
nct id: NCT03243240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gastrointestinal bleeding represents a serious clinical problem and a common cause of
      hospitalisation with a mortality rate of 6-10% for upper Gastrointestinal bleeding and of 4%
      for lower Gastrointestinal bleeding requires a multidisciplinary approach involving
      gastroenterologists, endoscopists, surgeons and radiologists.

      Gastrointestinal bleeding is self-limited in 80% of cases requiring only supportive measures.
      However, the persistence of bleeding represents a diagnostic challenge to locate the site of
      bleeding especially in severe bleeding and to determine, if possible its cause. This will
      allow to select the most appropriate therapeutic approach in order to reduce the morbidity
      and mortality, the length of hospitalisation and the transfusion requirements.

      Current diagnostic algorithms vary widely from institution to institution and from clinician
      to clinician. Imaging modalities remain the mainstay of the diagnostic approach. They include
      endoscopy, video capsule, radionuclide imaging, catheter angiography and multidetector
      computed tomography imaging.

      In recent years, Multidetector computed tomography has emerged as a promising technology to
      evaluate Gastrointestinal bleeding. The modality's ease of use and rapid results favour its
      use in any emergent situation. In addition, today's high-speed, narrow collimation
      multi-detector technology allows a large coverage area with minimal motion artifacts, with
      the ability to capture both arterial and venous phase with ease. Multidetector computed
      tomography is being increasingly used as this is a widely available, non-invasive and fast
      diagnostic technique that allows for visualisation of the entire intestinal tract and its
      lesions, the identification of vascularity and possible vascular abnormalities.
A number of 30 Patients with Acute Gastrointestinal bleeding will be included in the study.

      To maximise detection capabilities, it is crucial that Computed tomography angiography should
      begin as soon as possible while the patient is actively bleeding. Patients with active
      Gastrointestinal bleeding are assigned to intensive care units, and patients in shock are
      promptly resuscitated. Intensive care unit physicians provide appropriate monitoring for
      hemodynamically unstable patients undergoing Multidetector computed tomography angiography.
      Multidetector computed tomography angiography should be performed without prior oral
      administration of water or contrast material. Active contrast material extravasation within
      the bowel lumen is obscured by oral contrast material, leading to false-negative results.

      Data acquisition: Investigators will perform Multidetector computed tomography angiography
      with 16- Multislice computed tomography scanner, medical system bright speed. The protocol
      will include non-enhanced scanning then perform a triphasic angiography that includes
      arterial, portal and venous phases to detect acute Gastrointestinal bleeding.

      Images will be acquired with the following parameters slice thickness 5mm for the unenhanced
      phase and 1.25mm for the arterial phase and Porto-venous phases, pitch 1.375, 300 Miliambiar,
      120kilovolt and rotation time 0.7 seconds.

      Images acquired are reconstructed for coronal, sagittal, Volume Rendering and Maximum
      Intensity Projection images. A similar protocol may be used with a 64-Multislice computed
      tomography scanner.

      A dose of 1-2 ml/kg body weight of concentration 370mg/ml non-ionized contrast media will be
      administered at a rate of 4ml/sec, with an upper limit of 150ml. Venous access is an
      antecubital vein with a 14 or at least 18G cannula. The scan delay time for the arterial
      phase images is obtained by using bolus tracking with a circular region of interest
      positioned in the abdominal aorta and a predefined 90-housenfield unit bolus-trigger
      threshold to the start of automatic scanning. The coverage from just above the diaphragm to
      the Ischial tuberosities including the rectum in all cases.

      Study interpretation post processing will be performed with a 4.6 version workstation. All
      studies are reviewed in the axial plane and with multiplanar reformation images. Real-time
      maximum-intensity projection images facilitate rapid study interpretation for optimal case
      management.

      The radiologist will try to get the following information:

        -  presence or absence of bleeding.

        -  localise the site of bleeding.

        -  detect the cause of bleeding: tumour, Arteriovenous malformations….. The confirmation of
           the triphasic Multislice computed tomography results will be done by angiographic
           intervention and embolization of bleeding vessel
observational model: Case-Only
time perspective: Cross-Sectional
measure: Role of triphasic computed tomography imaging in detection of acute non variceal gastrointestinal tract bleeding
time frame: one year
description: Number of 30 patients with acute gastrointestinal bleeding will undergo multislice computed tomography angiography with 16 multislice computed tomography scanner with dose 1-2ml/kg body weight contrast media and the study will be revised to detect the contrast extravasation which means active bleeding, and will detect the cause of bleeding such as tumor, aneurysm, arteriovenous malformation....and confirmation of these results will be done by angiographic intervention and embolization of the bleeding vessel
intervention type: Diagnostic Test
intervention name: mutlidetector computed tomography
description: Multidetector computed tomography angiography with 16- MSCT scanner, medical system bright speed. Our protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute gastrointestinal bleeding.
Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and porto-venous phases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ghada Abdelsabour, resident
role: Principal Investigator
affiliation: Assiut University
last name: Hany Mohammed, Professor
phone: 01119159500
email: Hany.rad@yahoo.com
last name: Omran Khodary, Lecturer
phone: 01117298484
email: Omranshow@yahoo.com
citation: Geffroy Y, Rodallec MH, Boulay-Coletta I, Julles MC, Ridereau-Zins C, Zins M. Multidetector CT angiography in acute gastrointestinal bleeding: why, when, and how. Radiographics. 2011 May-Jun;31(3):E35-46. doi: 10.1148/rg.313105206. Erratum In: Radiographics. 2011 Nov-Dec;31(7):2114. Fulles, Marie-Christine [corrected to Julles, Marie-Christine]. Radiographics. 2011 Sep-Oct;31(5):1496.
PMID: 21721196
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ghada abdelsabour
investigator title: principle investigator
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage