<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/NCT03789383</url>
  </required_header>
  <id_info>
    <org_study_id>RFLTIUNE</org_study_id>
    <nct_id>NCT03789383</nct_id>
  </id_info>
  <brief_title>Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation</brief_title>
  <official_title>Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation in Al-Rajhy Liver Hospital in Upper Egypt.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic&#xD;
      liver diseases and acute liver failure .Even though many complications can occur after LT,&#xD;
      biliary complications (BC) are both common and potentially severe .&#xD;
&#xD;
      a prospective study and retrospective part from hospital records.&#xD;
&#xD;
      Aim of the study:&#xD;
&#xD;
        1. Detect frequency, risk factors for development of biliary complications post living&#xD;
           donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone,&#xD;
           cholangitis etc.…).&#xD;
&#xD;
        2. Evaluate outcomes of different biliary complications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of biliary complications</measure>
    <time_frame>1 year after liver transplantation</time_frame>
    <description>Biliary complications include biliary leak or stricture (anastomotic or non anastomotic), the investigator will record nature of complication , its time of presentation and number of hospital re-admissions due to biliary complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Type of intervention done to each complication</measure>
    <time_frame>1 year after liver transplantation</time_frame>
    <description>Intervention is either non surgical (ERCP or PTD) or surgical revision with detailed description of each intervention and if the intervention is successful or not (biliary stricture resolved by MRCP, improvement of liver functions and symptoms)</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Transplant; Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital,&#xD;
        Assiut university, Egypt.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver&#xD;
             hospital , Assiut university,Egypt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pediatric liver transplantation&#xD;
&#xD;
          -  cadaveric liver transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sara Sedeek</last_name>
    <phone>+201022177340</phone>
    <email>sara_ali@aun.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Al-Rajhy liver hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Sara Sedeek</last_name>
      <email>sara_ali@aun.edu.eg</email>
    </contact>
    <investigator>
      <last_name>Madiha El-attar</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed Abd-elmalek</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara Sedeek</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sara Ali Hassan</investigator_full_name>
    <investigator_title>Clinical teaching assistant in department of Tropical Medicine and Gastroenterology</investigator_title>
  </responsible_party>
  <!-- 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/NCT03789383
org study id: RFLTIUNE
nct id: NCT03789383
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic
      liver diseases and acute liver failure .Even though many complications can occur after LT,
      biliary complications (BC) are both common and potentially severe .

      a prospective study and retrospective part from hospital records.

      Aim of the study:

        1. Detect frequency, risk factors for development of biliary complications post living
           donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone,
           cholangitis etc.…).

        2. Evaluate outcomes of different biliary complications
observational model: Other
time perspective: Other
measure: Incidence of biliary complications
time frame: 1 year after liver transplantation
description: Biliary complications include biliary leak or stricture (anastomotic or non anastomotic), the investigator will record nature of complication , its time of presentation and number of hospital re-admissions due to biliary complications.
measure: Type of intervention done to each complication
time frame: 1 year after liver transplantation
description: Intervention is either non surgical (ERCP or PTD) or surgical revision with detailed description of each intervention and if the intervention is successful or not (biliary stricture resolved by MRCP, improvement of liver functions and symptoms)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sara Sedeek
phone: +201022177340
email: sara_ali@aun.edu.eg
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sara Ali Hassan
investigator title: Clinical teaching assistant in department of Tropical Medicine and Gastroenterology