<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/NCT04451447</url>
  </required_header>
  <id_info>
    <org_study_id>White test in LDLTx</org_study_id>
    <nct_id>NCT04451447</nct_id>
  </id_info>
  <brief_title>White Test in Intra-operative Detection of Donor Biliary Leak in LDLTx.</brief_title>
  <acronym>LDLTx</acronym>
  <official_title>Effectiveness and Sensitivity of White Test Versus Conventional Saline Test in Minimizing Biliary Leak in Partial Liver Resection in Living Donor Liver Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amr Abdelaal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Biliary leak is a common complication after partial liver resection in living donor liver&#xD;
      transplant. It debases the quality of the postoperative course and affects morbidity and&#xD;
      mortality. Detecting and localizing sites of biliary leak intraoperatively through bile&#xD;
      leakage testing is important as it helps in detection of bile leaking points on the cut&#xD;
      surface and decrease post-operative bile leak.&#xD;
&#xD;
      In this study we will assess the efficacy and sensitivity of using White test in comparison&#xD;
      to conventional saline test in detecting intra operative bile leakage in liver donor.&#xD;
&#xD;
      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content&#xD;
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,&#xD;
      for localization of bile leakage. The use of fat emulsion in bile leakage tests does not&#xD;
      require special equipment, contaminate the wound, cause allergic reaction or damage the bile&#xD;
      duct and surrounding tissues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative bile leakage is one of the commonest causes of sepsis and liver failure after&#xD;
      liver resection in liver donor [ Yamashita YI et al, 2001 ] [ Langer D et al, 2011 ].Various&#xD;
      studies have showed that the incidence of postoperative bile leakage after liver resection&#xD;
      ranges from 3 to 27% [ Erdogan D et al, 2008 ] [ Ishii H et al, 2011 ].&#xD;
&#xD;
      The timely detection and repair of intraoperative bile leakage is extremely important, but&#xD;
      small leakage points are often difficult to detect [ Liu Z et al, 2012 ]. There are different&#xD;
      methods for detecting and or preventing bile leakage after partial liver resection, including&#xD;
      bile leakage tests, which detect open bile duct stumps on the resection surface through&#xD;
      increasing fluid pressure within the duct [ Lo CM et al, 1998 ].&#xD;
&#xD;
      The conventional intraoperative saline test, which involves injecting an isotonic sodium&#xD;
      chloride solution through the cystic duct, has been used for detection of leaking points from&#xD;
      the transected liver surface [ Ijichi M et al, 2000 ]. One of the main problems in using the&#xD;
      conventional bile leakage test is that the isotonic sodium chloride solution is a transparent&#xD;
      solution. Therefore, it is hard to detect the point of bile leakage. A previous randomized&#xD;
      study stated that there is no advantage to using the isotonic sodium chloride solution for&#xD;
      the bile leakage test during liver resection [ Ijichi M et al, 2000 ].&#xD;
&#xD;
      During the past decade, several bile leak tests have been proposed, with none gaining wide&#xD;
      acceptance. The intraductal injection of saline is a low-cost and reproducible technique, but&#xD;
      the transparent solution makes this technique inadequate for detecting small ducts. The&#xD;
      injection of dye solutions (e.g. methylene blue and indocyanine green) has been recommended.&#xD;
      However, these solutions need to be dense in order to allow the visualization of the leak&#xD;
      site. The related disadvantages of this approach include the following: 1) the indelible&#xD;
      coloration of the transection surface, which can mask additional small open ducts, 2) the&#xD;
      impossibility to wash out the staining and, consequently, 3) potential reduced sensitivity&#xD;
      for the detection of leak with repeated tests. Some centres have reported the saturation of&#xD;
      the cut surface of the liver with hydrogen peroxide to detect bile leaks, however this&#xD;
      practice comes with a potential risk of expansion air embolism via open hepatic veins.&#xD;
&#xD;
      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content&#xD;
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,&#xD;
      for localization of bile leakage (Morris-Stiff G et al., 2009). The use of fat emulsion in&#xD;
      bile leakage tests does not require special equipment, contaminate the wound, cause allergic&#xD;
      reaction or damage the bile duct and surrounding tissues. It can easily be repeated the&#xD;
      number of times necessary to detect and close all leakage points, can pinpoint even small&#xD;
      leaks and is inexpensive. This technique is easier to perform than fluorescent imaging, and&#xD;
      is more sensitive and reliable compared with saline bile leakage test used alone (Leelawat K&#xD;
      et al., 2012; Kaibori M et al., 2011).&#xD;
&#xD;
      Recently, intraoperative application of the White test has been demonstrated to reduce the&#xD;
      incidence of postoperative bile leakage [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. In&#xD;
      this technique, bile leakage sites on the transected liver surface are noted by injecting a&#xD;
      fat emulsion solution through the cystic duct. The previous prospective observational studies&#xD;
      suggested that the fat emulsion solution used in the White test is easily recognized,&#xD;
      innocuous and harmeless to the tissues, and can be easily removed without misleading tissue&#xD;
      staining [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. Therefore, this prospective study&#xD;
      will assess whether the White test is better than the conventional saline test for the&#xD;
      intraoperative detection of bile leakage and better prevention of post-operative bile leakage&#xD;
      in partial resection in living donor liver transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Non randomized controlled Interventional trial Compare the study group with a historical cohort.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Compare one group with a historical cohort. masked outcome for the tested and control arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-operative detection of bile leak points</measure>
    <time_frame>Immediate Intra-operative</time_frame>
    <description>Detection and suturing of bile leak points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post-operative bile leak</measure>
    <time_frame>Early post-operative (one month)</time_frame>
    <description>post-operative bile leak - Biloma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>Early post-operative (one month)</time_frame>
    <description>Infected biloma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bile Leak</condition>
  <arm_group>
    <arm_group_label>white test arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline test arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.</intervention_name>
    <description>The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.</description>
    <arm_group_label>white test arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saline test (routine test)</intervention_name>
    <description>The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.</description>
    <arm_group_label>Saline test arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:patients who are candidate for liver donation) Criteria for donor of&#xD;
        living donor liver transplantation):&#xD;
&#xD;
          1. Potential donors must be healthy volunteers between the ages of 18 and 45 years.&#xD;
&#xD;
          2. BMI must be up to 28.&#xD;
&#xD;
          3. Blood group must be compatible; Rh compatibility was not a significant criterion.&#xD;
&#xD;
          4. Donors should have normal liver function and no medical comorbidities.&#xD;
&#xD;
          5. Liver biopsy was done to ensure that there is no occult hepatic pathology and to&#xD;
             establish the degree of steatosis that should be less than 20%.&#xD;
&#xD;
          6. Donors must have no history of upper abdominal surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Intra operative vascular or biliary complication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>amr abdelaal, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Amr Abdelaal</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>White test, Donor, liver transplantation, living donor</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>SMOFlipid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04451447
org study id: White test in LDLTx
nct id: NCT04451447
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Biliary leak is a common complication after partial liver resection in living donor liver
      transplant. It debases the quality of the postoperative course and affects morbidity and
      mortality. Detecting and localizing sites of biliary leak intraoperatively through bile
      leakage testing is important as it helps in detection of bile leaking points on the cut
      surface and decrease post-operative bile leak.

      In this study we will assess the efficacy and sensitivity of using White test in comparison
      to conventional saline test in detecting intra operative bile leakage in liver donor.

      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,
      for localization of bile leakage. The use of fat emulsion in bile leakage tests does not
      require special equipment, contaminate the wound, cause allergic reaction or damage the bile
      duct and surrounding tissues.
Postoperative bile leakage is one of the commonest causes of sepsis and liver failure after
      liver resection in liver donor [ Yamashita YI et al, 2001 ] [ Langer D et al, 2011 ].Various
      studies have showed that the incidence of postoperative bile leakage after liver resection
      ranges from 3 to 27% [ Erdogan D et al, 2008 ] [ Ishii H et al, 2011 ].

      The timely detection and repair of intraoperative bile leakage is extremely important, but
      small leakage points are often difficult to detect [ Liu Z et al, 2012 ]. There are different
      methods for detecting and or preventing bile leakage after partial liver resection, including
      bile leakage tests, which detect open bile duct stumps on the resection surface through
      increasing fluid pressure within the duct [ Lo CM et al, 1998 ].

      The conventional intraoperative saline test, which involves injecting an isotonic sodium
      chloride solution through the cystic duct, has been used for detection of leaking points from
      the transected liver surface [ Ijichi M et al, 2000 ]. One of the main problems in using the
      conventional bile leakage test is that the isotonic sodium chloride solution is a transparent
      solution. Therefore, it is hard to detect the point of bile leakage. A previous randomized
      study stated that there is no advantage to using the isotonic sodium chloride solution for
      the bile leakage test during liver resection [ Ijichi M et al, 2000 ].

      During the past decade, several bile leak tests have been proposed, with none gaining wide
      acceptance. The intraductal injection of saline is a low-cost and reproducible technique, but
      the transparent solution makes this technique inadequate for detecting small ducts. The
      injection of dye solutions (e.g. methylene blue and indocyanine green) has been recommended.
      However, these solutions need to be dense in order to allow the visualization of the leak
      site. The related disadvantages of this approach include the following: 1) the indelible
      coloration of the transection surface, which can mask additional small open ducts, 2) the
      impossibility to wash out the staining and, consequently, 3) potential reduced sensitivity
      for the detection of leak with repeated tests. Some centres have reported the saturation of
      the cut surface of the liver with hydrogen peroxide to detect bile leaks, however this
      practice comes with a potential risk of expansion air embolism via open hepatic veins.

      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,
      for localization of bile leakage (Morris-Stiff G et al., 2009). The use of fat emulsion in
      bile leakage tests does not require special equipment, contaminate the wound, cause allergic
      reaction or damage the bile duct and surrounding tissues. It can easily be repeated the
      number of times necessary to detect and close all leakage points, can pinpoint even small
      leaks and is inexpensive. This technique is easier to perform than fluorescent imaging, and
      is more sensitive and reliable compared with saline bile leakage test used alone (Leelawat K
      et al., 2012; Kaibori M et al., 2011).

      Recently, intraoperative application of the White test has been demonstrated to reduce the
      incidence of postoperative bile leakage [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. In
      this technique, bile leakage sites on the transected liver surface are noted by injecting a
      fat emulsion solution through the cystic duct. The previous prospective observational studies
      suggested that the fat emulsion solution used in the White test is easily recognized,
      innocuous and harmeless to the tissues, and can be easily removed without misleading tissue
      staining [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. Therefore, this prospective study
      will assess whether the White test is better than the conventional saline test for the
      intraoperative detection of bile leakage and better prevention of post-operative bile leakage
      in partial resection in living donor liver transplant.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Non randomized controlled Interventional trial Compare the study group with a historical cohort.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Compare one group with a historical cohort. masked outcome for the tested and control arms.
measure: Intra-operative detection of bile leak points
time frame: Immediate Intra-operative
description: Detection and suturing of bile leak points
measure: post-operative bile leak
time frame: Early post-operative (one month)
description: post-operative bile leak - Biloma
measure: Surgical site infection
time frame: Early post-operative (one month)
description: Infected biloma
arm group label: white test arm
arm group type: Experimental
description: The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.
arm group label: Saline test arm
arm group type: Other
description: The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.
intervention type: Procedure
intervention name: The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.
description: The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.
arm group label: white test arm
intervention type: Procedure
intervention name: Saline test (routine test)
description: The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.
arm group label: Saline test arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: amr abdelaal, prof
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Amr Abdelaal
investigator title: professor
mesh term: SMOFlipid
sharing ipd: No