<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/NCT03237247</url>
  </required_header>
  <id_info>
    <org_study_id>17100256</org_study_id>
    <nct_id>NCT03237247</nct_id>
  </id_info>
  <brief_title>Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis</brief_title>
  <official_title>Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cases with extrahepatic cholestasis are common and faced during day to day clinical practice,&#xD;
      however reaching the final etiology is sometimes challenging and needs investigations which&#xD;
      are usually expensive, may carry hazards to the patients, or inaccessible so we are in need&#xD;
      for a method which is easily available, affordable and safe for aiding in the differential&#xD;
      diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete&#xD;
      blood count in predicting the etiology of extrahepatic cholestasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extrahepatic cholestasis has various etiologies including benign causes (benign stricture,&#xD;
      chronic pancreatitis, choledochal cyst, mirizzi syndrome, etc...), choledocholithiasis,&#xD;
      malignant causes (cancer pancreas, gallbladder cancer, cholangiocarcinoma, etc....),&#xD;
      parasitic infestations (fasciola hepatica, ascaris lumbricoides, etc......) and other causes.&#xD;
      it is essential to detect the exact cause of extrahepatic cholestasis in order to determine&#xD;
      treatment options. diagnosing such conditions depends on clinical examination, laboratory&#xD;
      investigations, imaging studies, endoscopic procedures, biopsy and even surgical&#xD;
      intervention. some of these investigations are expensive, not available, or carry risk to the&#xD;
      patients. moreover non of them is accurate 100%. Complete blood count is already available,&#xD;
      easy to obtain, not invasive investigation. In these study we are trying to evaluate the role&#xD;
      of complete blood count parameters namely RDW, MPV, PDW, PCT, NLR, PLR in the differential&#xD;
      diagnosis of extrahepatic cholestasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>differential diagnosis of extrahepatic cholestasis</measure>
    <time_frame>10 days</time_frame>
    <description>complete blood count parameters</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Extrahepatic Cholestasis</condition>
  <arm_group>
    <arm_group_label>Benign</arm_group_label>
    <description>cases with benign biliary stricture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcular OJ</arm_group_label>
    <description>cases with calcular extrahepatic cholestasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Malignant Distal</arm_group_label>
    <description>cases with malignant distal extrahepatic cholestasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Malignant Proximal</arm_group_label>
    <description>cases with malignant proximal extrahepatic cholestasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrahepatic</arm_group_label>
    <description>cases with intrahepatic cholestasis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with extrahepatic cholestasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with extrahepatic cholestasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 14 years&#xD;
&#xD;
          -  previous bilio-pancreatic interventions&#xD;
&#xD;
          -  hemoglobinopathy&#xD;
&#xD;
          -  splenomegaly&#xD;
&#xD;
          -  myeloproliferative disorders&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  recent blood transfusion in less than one month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 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>Wael M Sayed</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>extrahepatic cholestasis, CBC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Cholestasis, Extrahepatic</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/NCT03237247
org study id: 17100256
nct id: NCT03237247
lead sponsor: 
has dmc: Yes
Cases with extrahepatic cholestasis are common and faced during day to day clinical practice,
      however reaching the final etiology is sometimes challenging and needs investigations which
      are usually expensive, may carry hazards to the patients, or inaccessible so we are in need
      for a method which is easily available, affordable and safe for aiding in the differential
      diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete
      blood count in predicting the etiology of extrahepatic cholestasis.
Extrahepatic cholestasis has various etiologies including benign causes (benign stricture,
      chronic pancreatitis, choledochal cyst, mirizzi syndrome, etc...), choledocholithiasis,
      malignant causes (cancer pancreas, gallbladder cancer, cholangiocarcinoma, etc....),
      parasitic infestations (fasciola hepatica, ascaris lumbricoides, etc......) and other causes.
      it is essential to detect the exact cause of extrahepatic cholestasis in order to determine
      treatment options. diagnosing such conditions depends on clinical examination, laboratory
      investigations, imaging studies, endoscopic procedures, biopsy and even surgical
      intervention. some of these investigations are expensive, not available, or carry risk to the
      patients. moreover non of them is accurate 100%. Complete blood count is already available,
      easy to obtain, not invasive investigation. In these study we are trying to evaluate the role
      of complete blood count parameters namely RDW, MPV, PDW, PCT, NLR, PLR in the differential
      diagnosis of extrahepatic cholestasis.
observational model: Case-Only
time perspective: Cross-Sectional
measure: differential diagnosis of extrahepatic cholestasis
time frame: 10 days
description: complete blood count parameters
arm group label: Benign
description: cases with benign biliary stricture
arm group label: Calcular OJ
description: cases with calcular extrahepatic cholestasis
arm group label: Malignant Distal
description: cases with malignant distal extrahepatic cholestasis
arm group label: Malignant Proximal
description: cases with malignant proximal extrahepatic cholestasis
arm group label: Intrahepatic
description: cases with intrahepatic cholestasis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Wael M Sayed
investigator title: principle investigator
mesh term: Cholestasis
mesh term: Cholestasis, Extrahepatic