<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/NCT03808649</url>
  </required_header>
  <id_info>
    <org_study_id>2019SDU-QILU-01</org_study_id>
    <nct_id>NCT03808649</nct_id>
  </id_info>
  <brief_title>Individualized Volume of Oral Contrast Agent in CT Enterography</brief_title>
  <official_title>Individualized Volume of Oral Contrast Agent Based on the Clinical Risk Factor in CT Enterography: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography,&#xD;
      but some patients were sufferring inadequate small bowel distension. So, it is important to&#xD;
      prescribe personalized regimen according to patient's personal characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CT enterography has become an important tool in the evaluation of small bowel diseases,&#xD;
      especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory&#xD;
      for the assessment of the bowel wall. So, it is important to find clinical risk factors for&#xD;
      inadequate small bowel distension and prescribe personalized regimen according to patient's&#xD;
      personal characteristics to reduce patient acceptance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 20, 2019</start_date>
  <completion_date type="Anticipated">July 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical risk factors for inadequate small bowel distention</measure>
    <time_frame>2 month</time_frame>
    <description>Number of clinical risk factors for inadequate small bowel distention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adequate small bowel distention</measure>
    <time_frame>4 month</time_frame>
    <description>The assessment system includes four parts&#xD;
Whether the contrast reached the caecum is evaluate and recorded as &quot;yes&quot; or &quot;no&quot;&#xD;
The overall presence of inhomogeneous contrast is evaluated and recorded as &quot;yes&quot; or &quot;no&quot;&#xD;
The maximum dimension of a single loop in each quadrant was recorded.&#xD;
The scale of loops of small bowel distended are evaluated and recorded as &quot;0%-25%&quot;,&quot;26%-50%&quot;,&quot;51%-75%&quot;,&quot;75%-100%&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>4 month</time_frame>
    <description>Side effects in 2 groups The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 4, in which a higher score represents a higher level of these targets.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>CTE</condition>
  <arm_group>
    <arm_group_label>Individualized group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1500ml of 2.5% mannitol</intervention_name>
    <description>1500ml of 2.5% mannitol was used in experimental group</description>
    <arm_group_label>Individualized group</arm_group_label>
    <arm_group_label>conventional group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>different volume of 2.5% mannitol</intervention_name>
    <description>different volume of 2.5% mannitol based on BMI was used in active comparator group</description>
    <arm_group_label>Individualized group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing CT enterography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of GI surgery&#xD;
&#xD;
          -  patients with known or suspected bowel obstruction or perforation&#xD;
&#xD;
          -  patients with severe chronic renal failure (creatinine clearance&lt;30 ml/min)&#xD;
&#xD;
          -  patients with uncontrolled hypertension (systolic blood pressure&gt;170 mm Hg, diastolic&#xD;
             blood pressure&gt;100 mm Hg)&#xD;
&#xD;
          -  patients with acute upper GI bleeding&#xD;
&#xD;
          -  patients with severe inflammatory bowel disease or megacolon&#xD;
&#xD;
          -  patients with documented allergy to intravascular contrast agent&#xD;
&#xD;
          -  patients with pregnancy or lactation&#xD;
&#xD;
          -  patients hemodynamically unstable&#xD;
&#xD;
          -  patients unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqing Li, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanqing Li, PhD, MD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yanqing Li, MD, PhD</last_name>
      <phone>86-531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</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/NCT03808649
org study id: 2019SDU-QILU-01
nct id: NCT03808649
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography,
      but some patients were sufferring inadequate small bowel distension. So, it is important to
      prescribe personalized regimen according to patient's personal characteristics.
CT enterography has become an important tool in the evaluation of small bowel diseases,
      especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory
      for the assessment of the bowel wall. So, it is important to find clinical risk factors for
      inadequate small bowel distension and prescribe personalized regimen according to patient's
      personal characteristics to reduce patient acceptance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Care Provider, Outcomes Assessor)
measure: Clinical risk factors for inadequate small bowel distention
time frame: 2 month
description: Number of clinical risk factors for inadequate small bowel distention
measure: Adequate small bowel distention
time frame: 4 month
description: The assessment system includes four parts
Whether the contrast reached the caecum is evaluate and recorded as "yes" or "no"
The overall presence of inhomogeneous contrast is evaluated and recorded as "yes" or "no"
The maximum dimension of a single loop in each quadrant was recorded.
The scale of loops of small bowel distended are evaluated and recorded as "0%-25%","26%-50%","51%-75%","75%-100%"
measure: Side effects
time frame: 4 month
description: Side effects in 2 groups The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 4, in which a higher score represents a higher level of these targets.
arm group label: Individualized group
arm group type: Active Comparator
description: Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.
arm group label: conventional group
arm group type: Experimental
description: Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.
intervention type: Drug
intervention name: 1500ml of 2.5% mannitol
description: 1500ml of 2.5% mannitol was used in experimental group
arm group label: Individualized group
arm group label: conventional group
intervention type: Drug
intervention name: different volume of 2.5% mannitol
description: different volume of 2.5% mannitol based on BMI was used in active comparator group
arm group label: Individualized group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yanqing Li, PhD, MD
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
last name: Yanqing Li, PhD, MD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: vice president of Qilu Hospital
mesh term: Mannitol