xml: <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/NCT05970159</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-216</org_study_id>
      <nct_id>NCT05970159</nct_id>
    </id_info>
    <brief_title>Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With Surgery</brief_title>
    <acronym>REAL</acronym>
    <official_title>The Impacts of preopeRative sErum Albumin Levels on Postoperative Outcomes in Chinese HCC Patients Treated With Surgical Operation: REAL Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</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>
        This is an observational and retrospective cohort study to evaluate the impact of the&#xD;
        preoperative serum albumin concentration on postoperative outcomes among hepatocellular&#xD;
        carcinoma (HCC) patients who received hepatectomy or liver transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The impact of hypoalbuminemia on postoperative outcomes has been the subject of several&#xD;
        investigations which agreed that hypoalbuminemia is an important risk factor for mortality&#xD;
        and morbidity after various types of surgical operations. Unfortunately, there are limited&#xD;
        real-world data to establish the correlation between hypoalbuminemia and hepatectomy or liver&#xD;
        transplantation postoperative complications in China. This study will evaluate the impact of&#xD;
        the preoperative serum albumin concentration on postoperative outcomes among hepatocellular&#xD;
        carcinoma (HCC) patients who received hepatectomy or liver transplantation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Complications following surgery that occurred during hospitalization. For the hepatectomy cohort of patients, postoperative complications included incision, urinary tract and abdominal infections, pleural fluid, ascites, post-hepatectomy hemorrhage bile leakage, post hepatectomy liver failure, renal insufficiency, multiple organ dysfunction syndrome, pneumonia and pulmonary embolism, etc. For the LT cohort of patients, postoperative complications included primary nonfunction, hemorrhage, hepatic artery thrombosis, hepatic vein thrombosis, bile leakage, acute kidney injury, deep wound infections and catheter-related infections.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Death occurring during the postoperative hospital stay.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Days of hospital stay</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>The length of stay in hospital after surgery.</description>
    </other_outcome>
    <other_outcome>
      <measure>Days of ICU stay</measure>
      <time_frame>up to 4 weeks</time_frame>
      <description>The length of stay in ICU after surgery.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Hypoalbuminemia group</arm_group_label>
      <description>Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are &lt; 36g/L.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal group</arm_group_label>
      <description>Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who met the criteria for inclusion in this real-world study from Zhongshan&#xD;
          Hospital, Fudan University will be included. According to a preliminary feasibility&#xD;
          department investigation, a sample size of approximately 480 subjects will be enrolled in&#xD;
          this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who diagnosed with HCC confirmed by histology/cytology or clinically criteria&#xD;
               regardless of gender.&#xD;
  &#xD;
            -  HCC Patients who had received the first hepatectomy or liver transplantation (LT).&#xD;
  &#xD;
            -  Age ≥18 years at the start date of the hepatectomy or LT.&#xD;
  &#xD;
            -  HCC patients who had the value of serum albumin within 7 days prior to the surgery.&#xD;
  &#xD;
            -  HCC patients who had exemption of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  HCC Patients with extrahepatic metastasis or other malignant tumours.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Huichuan Sun</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Huichuan Sun</last_name>
      <phone>+86-21-64041990</phone>
      <email>sun.huichuan@zs-hospital.sh.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hui Li</last_name>
      <phone>+86-21-64041990</phone>
      <email>lihui0801@foxmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan Hospital, Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui Li</last_name>
        <phone>+86-21-64041990</phone>
        <email>lihui0801@foxmail.com</email>
      </contact>
      <investigator>
        <last_name>Huichuan Sun</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Ma KW, Cheung TT, She WH, Chok KSH, Chan ACY, Dai WC, Lo CM. Risk prediction model for major complication after hepatectomy for malignant tumour - A validated scoring system from a university center. Surg Oncol. 2017 Dec;26(4):446-452. doi: 10.1016/j.suronc.2017.08.007. Epub 2017 Sep 9.</citation>
      <PMID>29113664</PMID>
    </results_reference>
    <results_reference>
      <citation>Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.</citation>
      <PMID>15383797</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hepatocellular carcinoma</keyword>
    <keyword>Albumin</keyword>
    <keyword>Hepatectomy</keyword>
    <keyword>Liver transplantation</keyword>
    <keyword>Postoperative outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970159
  org study id: B2023-216
  nct id: NCT05970159
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an observational and retrospective cohort study to evaluate the impact of the
        preoperative serum albumin concentration on postoperative outcomes among hepatocellular
        carcinoma (HCC) patients who received hepatectomy or liver transplantation.
  The impact of hypoalbuminemia on postoperative outcomes has been the subject of several
        investigations which agreed that hypoalbuminemia is an important risk factor for mortality
        and morbidity after various types of surgical operations. Unfortunately, there are limited
        real-world data to establish the correlation between hypoalbuminemia and hepatectomy or liver
        transplantation postoperative complications in China. This study will evaluate the impact of
        the preoperative serum albumin concentration on postoperative outcomes among hepatocellular
        carcinoma (HCC) patients who received hepatectomy or liver transplantation.
  observational model: Cohort
  time perspective: Retrospective
  measure: Postoperative complications
  time frame: up to 2 weeks
  description: Complications following surgery that occurred during hospitalization. For the hepatectomy cohort of patients, postoperative complications included incision, urinary tract and abdominal infections, pleural fluid, ascites, post-hepatectomy hemorrhage bile leakage, post hepatectomy liver failure, renal insufficiency, multiple organ dysfunction syndrome, pneumonia and pulmonary embolism, etc. For the LT cohort of patients, postoperative complications included primary nonfunction, hemorrhage, hepatic artery thrombosis, hepatic vein thrombosis, bile leakage, acute kidney injury, deep wound infections and catheter-related infections.
  measure: Mortality
  time frame: up to 2 weeks
  description: Death occurring during the postoperative hospital stay.
  measure: Days of hospital stay
  time frame: up to 2 weeks
  description: The length of stay in hospital after surgery.
  measure: Days of ICU stay
  time frame: up to 4 weeks
  description: The length of stay in ICU after surgery.
  arm group label: Hypoalbuminemia group
  description: Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are < 36g/L.
  arm group label: Normal group
  description: Patients with hepatocellular carcinoma whose preoperative serum albumin concentration are ≥ 36g/L.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Huichuan Sun
  role: Principal Investigator
  affiliation: Fudan University
  last name: Huichuan Sun
  phone: +86-21-64041990
  email: sun.huichuan@zs-hospital.sh.cn
  last name: Hui Li
  phone: +86-21-64041990
  email: lihui0801@foxmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  citation: Ma KW, Cheung TT, She WH, Chok KSH, Chan ACY, Dai WC, Lo CM. Risk prediction model for major complication after hepatectomy for malignant tumour - A validated scoring system from a university center. Surg Oncol. 2017 Dec;26(4):446-452. doi: 10.1016/j.suronc.2017.08.007. Epub 2017 Sep 9.
  PMID: 29113664
  citation: Poon RT, Fan ST, Lo CM, Liu CL, Lam CM, Yuen WK, Yeung C, Wong J. Improving perioperative outcome expands the role of hepatectomy in management of benign and malignant hepatobiliary diseases: analysis of 1222 consecutive patients from a prospective database. Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10. doi: 10.1097/01.sla.0000141195.66155.0c.
  PMID: 15383797
  responsible party type: Sponsor
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: No