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/NCT06013657</url>
    </required_header>
    <id_info>
      <org_study_id>DRCiptoMGH 19-11-1313</org_study_id>
      <nct_id>NCT06013657</nct_id>
    </id_info>
    <brief_title>Surgical Resection for Hepatocellular Carcinoma</brief_title>
    <official_title>Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr Cipto Mangunkusumo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dr Cipto Mangunkusumo General 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>
        Hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global&#xD;
        cancer death. Surgical resection of the afflicted areas of the liver is one of the treatment&#xD;
        methods for this condition. In this retrospective research, the investigators explore the&#xD;
        outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection&#xD;
        from 2010 to 2021 in Cipto Mangunkusumo General Hospital, Jakarta. The main outcome is&#xD;
        mortality and the secondary outcomes are factors predicting mortality after resection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design This is a retrospective cohort study.&#xD;
  &#xD;
        Treatment of Hepatocellular Carcinoma Patients in RSCM HCC patients are managed by a&#xD;
        multidisciplinary team (MDT) consisting of hepatologists, radiologists, pathologists,&#xD;
        radiation oncologists, surgeons, and other specialists related to the patient's condition.&#xD;
        Confirmed HCC patients are discussed in a weekly MDT team meeting. The meeting assigned&#xD;
        patients to treatment options according to the Barcelona Clinic Liver Center (BCLC) staging&#xD;
        system, patient preference, and other clinical considerations. Resection is considered for&#xD;
        patients at very early (BCLC 0) or early (BCLC A) HCC stages. This includes CP class A&#xD;
        patients with a single tumor or less than three small (&lt;3 cm) tumors. Patients assigned to&#xD;
        surgical resection underwent either laparoscopic or open surgery. One to four segments of the&#xD;
        liver were removed. Tissue samples were taken for further pathologic examination.&#xD;
  &#xD;
        Ethical Clearance The ethics committee of The Faculty of Medicine, University of Indonesia,&#xD;
        approved this study by giving an ethical clearance with protocol number 19-11-1313. Informed&#xD;
        consent was taken from all patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">June 1, 2022</completion_date>
    <primary_completion_date type="Actual">March 25, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>Through study completion, an average of 3 years</time_frame>
      <description>Mortality status of patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>Within one week before surgery</time_frame>
      <description>Age in years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sex</measure>
      <time_frame>Within one week before surgery</time_frame>
      <description>Male or Female</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Etiology</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child-Pugh classification</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BCLC Classification</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AFP Levels</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Divided into &lt;400 and &gt;=400</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of tumors</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Divided into single and multiple tumors according to imaging findings</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Largest diameter of tumor</measure>
      <time_frame>Within one month before surgery</time_frame>
      <description>Measured in cm according to imaging</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgery method</measure>
      <time_frame>During surgery</time_frame>
      <description>Laparoscopy or open surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Segments resected</measure>
      <time_frame>During surgery</time_frame>
      <description>1-4 segments</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cirrhosis</measure>
      <time_frame>Within one month after surgery</time_frame>
      <description>Presence of cirrhosis in histopathological findings</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Edmondson's grading</measure>
      <time_frame>Within one month after surgery</time_frame>
      <description>Histopathological grading divided into 1 to 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor differentiation</measure>
      <time_frame>Within one month after surgery</time_frame>
      <description>Histopathological grading divided well, moderate, moderate to poor, and poor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>An average of two weeks</time_frame>
      <description>Measured in days from admission to discharge</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">91</enrollment>
    <condition>Resectable Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>Liver resection</arm_group_label>
      <description>Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Liver Resection</intervention_name>
      <description>Resection of a part of the liver afflicted by hepatocellular carcinoma</description>
      <arm_group_label>Liver resection</arm_group_label>
      <other_name>Hepatectomy</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study used a total population sampling of all patients undergoing liver resection in&#xD;
          Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from&#xD;
          2010 to 2021. Patients undergoing liver resection in other hospitals were excluded, even&#xD;
          though diagnosis or further care is done in RSCM. In addition, patients with other&#xD;
          malignancies or undergoing other treatment methods were excluded.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed&#xD;
               diagnosis of hepatocellular carcinoma from 2010 to 2021&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing liver resection in other hospitals were excluded, even though&#xD;
               diagnosis or further care is done in Cipto Mangunkusumo hospital&#xD;
  &#xD;
            -  Patients with other malignancies&#xD;
  &#xD;
            -  Patients undergoing other treatment methods for hepatocellular carcinoma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dr. Cipto Mangunkusumo General Hospital</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10440</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
      <investigator_full_name>Ridho Ardhi Syaiful</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>carcinoma,hepatocellular</keyword>
    <keyword>liver neoplasms</keyword>
    <keyword>hepatectomy</keyword>
    <keyword>mortality</keyword>
    <keyword>prognostic</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.</ipd_description>
    </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/NCT06013657
  org study id: DRCiptoMGH 19-11-1313
  nct id: NCT06013657
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global
        cancer death. Surgical resection of the afflicted areas of the liver is one of the treatment
        methods for this condition. In this retrospective research, the investigators explore the
        outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection
        from 2010 to 2021 in Cipto Mangunkusumo General Hospital, Jakarta. The main outcome is
        mortality and the secondary outcomes are factors predicting mortality after resection.
  Study design This is a retrospective cohort study.
  
        Treatment of Hepatocellular Carcinoma Patients in RSCM HCC patients are managed by a
        multidisciplinary team (MDT) consisting of hepatologists, radiologists, pathologists,
        radiation oncologists, surgeons, and other specialists related to the patient's condition.
        Confirmed HCC patients are discussed in a weekly MDT team meeting. The meeting assigned
        patients to treatment options according to the Barcelona Clinic Liver Center (BCLC) staging
        system, patient preference, and other clinical considerations. Resection is considered for
        patients at very early (BCLC 0) or early (BCLC A) HCC stages. This includes CP class A
        patients with a single tumor or less than three small (<3 cm) tumors. Patients assigned to
        surgical resection underwent either laparoscopic or open surgery. One to four segments of the
        liver were removed. Tissue samples were taken for further pathologic examination.
  
        Ethical Clearance The ethics committee of The Faculty of Medicine, University of Indonesia,
        approved this study by giving an ethical clearance with protocol number 19-11-1313. Informed
        consent was taken from all patients.
  observational model: Cohort
  time perspective: Other
  measure: Mortality
  time frame: Through study completion, an average of 3 years
  description: Mortality status of patients
  measure: Age
  time frame: Within one week before surgery
  description: Age in years
  measure: Sex
  time frame: Within one week before surgery
  description: Male or Female
  measure: Etiology
  time frame: Within one month before surgery
  description: Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.
  measure: Child-Pugh classification
  time frame: Within one month before surgery
  description: Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.
  measure: BCLC Classification
  time frame: Within one month before surgery
  description: Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.
  measure: AFP Levels
  time frame: Within one month before surgery
  description: Divided into <400 and >=400
  measure: Number of tumors
  time frame: Within one month before surgery
  description: Divided into single and multiple tumors according to imaging findings
  measure: Largest diameter of tumor
  time frame: Within one month before surgery
  description: Measured in cm according to imaging
  measure: Surgery method
  time frame: During surgery
  description: Laparoscopy or open surgery
  measure: Segments resected
  time frame: During surgery
  description: 1-4 segments
  measure: Cirrhosis
  time frame: Within one month after surgery
  description: Presence of cirrhosis in histopathological findings
  measure: Edmondson's grading
  time frame: Within one month after surgery
  description: Histopathological grading divided into 1 to 4
  measure: Tumor differentiation
  time frame: Within one month after surgery
  description: Histopathological grading divided well, moderate, moderate to poor, and poor
  measure: Length of stay
  time frame: An average of two weeks
  description: Measured in days from admission to discharge
  arm group label: Liver resection
  description: Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.
  intervention type: Procedure
  intervention name: Liver Resection
  description: Resection of a part of the liver afflicted by hepatocellular carcinoma
  arm group label: Liver resection
  other name: Hepatectomy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Dr Cipto Mangunkusumo General Hospital
  investigator full name: Ridho Ardhi Syaiful
  investigator title: Principal investigator
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: Undecided
  ipd description: Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.