<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/NCT02991339</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-SHC-DAJ</org_study_id>
    <nct_id>NCT02991339</nct_id>
  </id_info>
  <brief_title>The Effects of Dexamethasone Administration on Jaundice Following Liver Resection</brief_title>
  <official_title>The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators were aiming to evaluate whether dexamethasone administration accelerates&#xD;
      the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy&#xD;
      liver failure and its safety in the subjects who developed elevated serum total bilirubin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative jaundice is one of the most common complications after hepatectomy for various&#xD;
      liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone,&#xD;
      were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction&#xD;
      or liver failure. It was reported that glucocorticoids decrease the rates of liver&#xD;
      dysfunction or mortality in those patients. However, whether post-operative glucocorticoids&#xD;
      administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure&#xD;
      (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether&#xD;
      dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and&#xD;
      decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>period in days from the day serum total bilirubin (TB) &gt;=2.5 ULN to the day TB decreased to 1.5 ULN</measure>
    <time_frame>up to 30 days after hepatectomy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The dynamic change of serum total bilirubin</measure>
    <time_frame>up to 30 days after hepatectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inhospital expenses</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative complications, including postoperative liver failure, infection and GI bleeding</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The dynamic change of serum glutamine aminotransferase</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Liver Dysfunction</condition>
  <condition>Hepatectomy</condition>
  <condition>Bilirubinaemia</condition>
  <condition>Jaundice</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone 10 mg iv on day 1 and day 2, then 5 mg iv on day 3. For the patients the serum total bilirubin did not decrease to 1.5 ULN, then 5 mg iv on day 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients are not treated with glucocorticoids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <other_name>Dexamethasone Sodium Phosphate Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients underwent open hepatectomy for liver tumors&#xD;
&#xD;
          -  Preoperative liver function was Child-Pugh A, and the liver shear wave elastography&#xD;
             (SWE) &lt; 30 kPa&#xD;
&#xD;
          -  Postoperative serum total bilirubin &gt; 2.5 ULN in 7 days after hepatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hilar cholangiocarcinoma or other disease with obstructive jaundice&#xD;
&#xD;
          -  Complicating disease with severe dysfunction in respiratory or circulation system or&#xD;
             kidney.&#xD;
&#xD;
          -  Patients with contraindication of glucocorticoids, including severe infection, active&#xD;
             GI bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui-Chuan Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liver Cancer Insitute and Zhongshan Hospital, Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>180 Fenglin Road</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.</citation>
    <PMID>21236455</PMID>
  </reference>
  <results_reference>
    <citation>Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.</citation>
    <PMID>20940288</PMID>
  </results_reference>
  <results_reference>
    <citation>Thursz MR, Forrest EH, Ryder S; STOPAH investigators. Prednisolone or Pentoxifylline for Alcoholic Hepatitis. N Engl J Med. 2015 Jul 16;373(3):282-3. doi: 10.1056/NEJMc1506342. No abstract available.</citation>
    <PMID>26176387</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen JF, Wang KW, Zhang SQ, Lei ZY, Xie JQ, Zhu JY, Weng WZ, Gao ZL, Lin BL. Dexamethasone in outcome of patients with hepatitis B virus-related acute-on-chronic liver failure. J Gastroenterol Hepatol. 2014 Apr;29(4):800-6. doi: 10.1111/jgh.12454.</citation>
    <PMID>24224656</PMID>
  </results_reference>
  <results_reference>
    <citation>Yamashita Y, Shimada M, Hamatsu T, Rikimaru T, Tanaka S, Shirabe K, Sugimachi K. Effects of preoperative steroid administration on surgical stress in hepatic resection: prospective randomized trial. Arch Surg. 2001 Mar;136(3):328-33. doi: 10.1001/archsurg.136.3.328.</citation>
    <PMID>11231856</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Hui-Chuan Sun</investigator_full_name>
    <investigator_title>Deputy Director of the Department of Liver Surgery</investigator_title>
  </responsible_party>
  <keyword>Dexamethasone</keyword>
  <keyword>Liver Dysfunction</keyword>
  <keyword>Hepatectomy</keyword>
  <keyword>Bilirubinaemia</keyword>
  <keyword>Jaundice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Hyperbilirubinemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Dexamethasone 21-phosphate</mesh_term>
    <mesh_term>BB 1101</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/NCT02991339
org study id: ZS-SHC-DAJ
nct id: NCT02991339
lead sponsor: 
has dmc: No
The investigators were aiming to evaluate whether dexamethasone administration accelerates
      the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy
      liver failure and its safety in the subjects who developed elevated serum total bilirubin.
Post-operative jaundice is one of the most common complications after hepatectomy for various
      liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone,
      were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction
      or liver failure. It was reported that glucocorticoids decrease the rates of liver
      dysfunction or mortality in those patients. However, whether post-operative glucocorticoids
      administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure
      (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether
      dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and
      decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN
time frame: up to 30 days after hepatectomy
measure: The dynamic change of serum total bilirubin
time frame: up to 30 days after hepatectomy
measure: length of hospital stay
time frame: up to 30 days after surgery
measure: inhospital expenses
time frame: up to 30 days after surgery
measure: post-operative complications, including postoperative liver failure, infection and GI bleeding
time frame: up to 30 days after surgery
measure: The dynamic change of serum glutamine aminotransferase
time frame: up to 30 days after surgery
arm group label: Dexamethasone
arm group type: Experimental
description: Dexamethasone 10 mg iv on day 1 and day 2, then 5 mg iv on day 3. For the patients the serum total bilirubin did not decrease to 1.5 ULN, then 5 mg iv on day 4.
arm group label: control
arm group type: No Intervention
description: Patients are not treated with glucocorticoids.
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
arm group label: Dexamethasone
other name: Dexamethasone Sodium Phosphate Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hui-Chuan Sun, MD
role: Principal Investigator
affiliation: Liver Cancer Insitute and Zhongshan Hospital, Fudan University
facility: 
country: China
citation: Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
PMID: 21236455
citation: Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.
PMID: 20940288
citation: Thursz MR, Forrest EH, Ryder S; STOPAH investigators. Prednisolone or Pentoxifylline for Alcoholic Hepatitis. N Engl J Med. 2015 Jul 16;373(3):282-3. doi: 10.1056/NEJMc1506342. No abstract available.
PMID: 26176387
citation: Chen JF, Wang KW, Zhang SQ, Lei ZY, Xie JQ, Zhu JY, Weng WZ, Gao ZL, Lin BL. Dexamethasone in outcome of patients with hepatitis B virus-related acute-on-chronic liver failure. J Gastroenterol Hepatol. 2014 Apr;29(4):800-6. doi: 10.1111/jgh.12454.
PMID: 24224656
citation: Yamashita Y, Shimada M, Hamatsu T, Rikimaru T, Tanaka S, Shirabe K, Sugimachi K. Effects of preoperative steroid administration on surgical stress in hepatic resection: prospective randomized trial. Arch Surg. 2001 Mar;136(3):328-33. doi: 10.1001/archsurg.136.3.328.
PMID: 11231856
responsible party type: Principal Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Hui-Chuan Sun
investigator title: Deputy Director of the Department of Liver Surgery
mesh term: Liver Diseases
mesh term: Jaundice
mesh term: Hyperbilirubinemia
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Dexamethasone 21-phosphate
mesh term: BB 1101
sharing ipd: No