<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/NCT03768141</url>
  </required_header>
  <id_info>
    <org_study_id>v.1.3.2011.11.30</org_study_id>
    <nct_id>NCT03768141</nct_id>
  </id_info>
  <brief_title>International Liver Surgery Outcomes Study</brief_title>
  <acronym>LiverGroup</acronym>
  <official_title>International Study on the Outcomes of Liver Surgery - LiverGroup.Org</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Free Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Miguel Servet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Free Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</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 study was to designed to measure the true worldwide practice of liver surgery and&#xD;
      associated outcomes by recruiting multiple international centres, committing to consecutive&#xD;
      patient registration per surgeon and undergo rigorous data validation. It is hoped that these&#xD;
      data will provide a more appropriate guide to inform surgeons and patients to assess which&#xD;
      level of complexity should be routinely offered for high tumour burden and anatomically&#xD;
      difficult scenarios.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver surgery was associated with at least 10% mortality in the 1970's. The safety of liver&#xD;
      surgery has dramatically improved since with a mortality of now around 1-2%. Individual&#xD;
      centres postulate that a perioperative mortality close to 0% should be the standard of major&#xD;
      liver resection. Despite these claims, epidemiological studies showed a mortality rate of 6%.&#xD;
      Outcomes in liver surgery are likely influenced by indications, complexity, centre and&#xD;
      surgeon skills, equipment, centre and surgeon experience. The aim of LiverGroup.org is to&#xD;
      develop an international data set on the outcomes of liver resections among a large number of&#xD;
      international surgeons. The 'collaborative' model for 'snapshot' clinical audit is now well&#xD;
      established and such research is a novel approach for assessing current practice in a short&#xD;
      period of time. The primary objective of the study is to provide a verified record of the&#xD;
      true perioperative morbidity and mortality of a representative set of liver surgeons&#xD;
      worldwide in 2019. Secondary objectives include risk factors for mortality and morbidity&#xD;
      using multivariable regression models. Any surgeon performing liver resections is eligible to&#xD;
      participate in LiverGroup.org. All consecutive cases will be included and there are no&#xD;
      minimum patient numbers per centre. Liver transplantation is excluded. There will be 3 months&#xD;
      of prospective patient enrolment and 3 months follow up within the 12-month frame, January to&#xD;
      December 2019. All liver resections, all indications, as well as all co-morbidities will be&#xD;
      included. Liver transplantation, imaging-guided ablations and liver biopsies are excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>90 Days</target_duration>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>From operation until 90 days postoperatively</time_frame>
    <description>Death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>From operation until 90 days postoperatively</time_frame>
    <description>Postoperative complications according the the Clavien-Dindo classification, the &quot;liver Failure, Ascites, Bile leakage, Infection, Bleeding&quot; (FABIB) liver specific classification, as well as the novel Comprehensive Complications Index® (CCI® ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver failure rate</measure>
    <time_frame>From operation until 90 days postoperative</time_frame>
    <description>Posthepatectomy liver failure will be assessed according to the FABIB Classification, the &quot;International Study Group of Liver Surgery&quot; (ISGLS) criteria as well as the 50-50 criteria up to 90 days postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>From operation until discharge from the hospital or up to 90 days postoperatively.</time_frame>
    <description>The length of hospital stay is defined as the duration of hospitalization from the day of the operation until the day of discharge from the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalisation rate</measure>
    <time_frame>From operation until 90 days postoperatively</time_frame>
    <description>Readmission to any hospital</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2500</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Liver surgery</arm_group_label>
    <description>Any type of liver surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver surgery</intervention_name>
    <description>All indications (including benign and living donor resections), all co-morbidities, open, laparoscopic or robotic, single wedge resections to extended liver resections, single or two-stage hepatectomies, procedures with liver volume enhancement such as portal vein embolization (PVE), portal vein ligation (PVL), &quot;Associating Liver Partition and Portal vein Ligation for Staged hepatectomy&quot; (ALPPS), resections involving cold perfusion (ex-situ and ante-situ)</description>
    <arm_group_label>Liver surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any adult patient undergoing liver surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All indications (including benign and living donor resections)&#xD;
&#xD;
          -  All co-morbidities&#xD;
&#xD;
          -  Open, laparoscopic or robotic&#xD;
&#xD;
          -  Single wedge resections to extended liver resections&#xD;
&#xD;
          -  Single or two-stage hepatectomies&#xD;
&#xD;
          -  Procedures with liver volume enhancement such as PVE, PVL, ALPPS.&#xD;
&#xD;
          -  Resections involving cold perfusion (ex-situ and ante-situ)&#xD;
&#xD;
          -  There are no exclusion criteria as related to indication, age or comorbidities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver transplantation&#xD;
&#xD;
          -  Imaging-guided liver ablation techniques alone&#xD;
&#xD;
          -  Liver biopsies&#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>Massimo Malagò, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Free Hospital, London, UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Zaragoza, Spain</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://LiverGroup.org</url>
    <description>The official clinical trial management system (CTMS) of LiverGroup.org</description>
  </link>
  <link>
    <url>http://www.rBiostatistics.com</url>
    <description>Cloud Graphical User Interface for R Statistics - Statistical software for data analysis</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Free Hospital NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Dimitri Raptis</investigator_full_name>
    <investigator_title>Senior Clinical Fellow</investigator_title>
  </responsible_party>
  <keyword>Liver</keyword>
  <keyword>Surgery</keyword>
  <keyword>Outcomes</keyword>
  <keyword>Snapshot</keyword>
  <keyword>Collaborative</keyword>
  <keyword>International</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets generated and analysed during the current study will be available upon request from the Management Committee of LiverGroup.org. The study Primary Investigators will act as the custodians of the data. The data, however, belong to all collaborators. The Steering and Management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision. All data provided will be fully anonymized without any patient identifiers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will become available after the completion and publication of the first study generated by LiverGroup.org</ipd_time_frame>
    <ipd_access_criteria>The steering and management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision.</ipd_access_criteria>
    <ipd_url>https://livergroup.org/?q=protocol_full_version</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03768141/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03768141
org study id: v.1.3.2011.11.30
nct id: NCT03768141
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was to designed to measure the true worldwide practice of liver surgery and
      associated outcomes by recruiting multiple international centres, committing to consecutive
      patient registration per surgeon and undergo rigorous data validation. It is hoped that these
      data will provide a more appropriate guide to inform surgeons and patients to assess which
      level of complexity should be routinely offered for high tumour burden and anatomically
      difficult scenarios.
Liver surgery was associated with at least 10% mortality in the 1970's. The safety of liver
      surgery has dramatically improved since with a mortality of now around 1-2%. Individual
      centres postulate that a perioperative mortality close to 0% should be the standard of major
      liver resection. Despite these claims, epidemiological studies showed a mortality rate of 6%.
      Outcomes in liver surgery are likely influenced by indications, complexity, centre and
      surgeon skills, equipment, centre and surgeon experience. The aim of LiverGroup.org is to
      develop an international data set on the outcomes of liver resections among a large number of
      international surgeons. The 'collaborative' model for 'snapshot' clinical audit is now well
      established and such research is a novel approach for assessing current practice in a short
      period of time. The primary objective of the study is to provide a verified record of the
      true perioperative morbidity and mortality of a representative set of liver surgeons
      worldwide in 2019. Secondary objectives include risk factors for mortality and morbidity
      using multivariable regression models. Any surgeon performing liver resections is eligible to
      participate in LiverGroup.org. All consecutive cases will be included and there are no
      minimum patient numbers per centre. Liver transplantation is excluded. There will be 3 months
      of prospective patient enrolment and 3 months follow up within the 12-month frame, January to
      December 2019. All liver resections, all indications, as well as all co-morbidities will be
      included. Liver transplantation, imaging-guided ablations and liver biopsies are excluded.
observational model: Cohort
time perspective: Prospective
measure: Mortality rate
time frame: From operation until 90 days postoperatively
description: Death
measure: Complication rate
time frame: From operation until 90 days postoperatively
description: Postoperative complications according the the Clavien-Dindo classification, the "liver Failure, Ascites, Bile leakage, Infection, Bleeding" (FABIB) liver specific classification, as well as the novel Comprehensive Complications Index® (CCI® ).
measure: Liver failure rate
time frame: From operation until 90 days postoperative
description: Posthepatectomy liver failure will be assessed according to the FABIB Classification, the "International Study Group of Liver Surgery" (ISGLS) criteria as well as the 50-50 criteria up to 90 days postoperatively.
measure: Hospital stay
time frame: From operation until discharge from the hospital or up to 90 days postoperatively.
description: The length of hospital stay is defined as the duration of hospitalization from the day of the operation until the day of discharge from the hospital.
measure: Re-hospitalisation rate
time frame: From operation until 90 days postoperatively
description: Readmission to any hospital
arm group label: Liver surgery
description: Any type of liver surgery
intervention type: Procedure
intervention name: Liver surgery
description: All indications (including benign and living donor resections), all co-morbidities, open, laparoscopic or robotic, single wedge resections to extended liver resections, single or two-stage hepatectomies, procedures with liver volume enhancement such as portal vein embolization (PVE), portal vein ligation (PVL), "Associating Liver Partition and Portal vein Ligation for Staged hepatectomy" (ALPPS), resections involving cold perfusion (ex-situ and ante-situ)
arm group label: Liver surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Malagò, MD, PhD
role: Principal Investigator
affiliation: Royal Free Hospital, London, UK
facility: 
facility: 
country: Spain
country: United Kingdom
url: https://LiverGroup.org
description: The official clinical trial management system (CTMS) of LiverGroup.org
url: http://www.rBiostatistics.com
description: Cloud Graphical User Interface for R Statistics - Statistical software for data analysis
responsible party type: Principal Investigator
investigator affiliation: Royal Free Hospital NHS Foundation Trust
investigator full name: Dimitri Raptis
investigator title: Senior Clinical Fellow
mesh term: Liver Diseases
sharing ipd: Yes
ipd description: The datasets generated and analysed during the current study will be available upon request from the Management Committee of LiverGroup.org. The study Primary Investigators will act as the custodians of the data. The data, however, belong to all collaborators. The Steering and Management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision. All data provided will be fully anonymized without any patient identifiers.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The data will become available after the completion and publication of the first study generated by LiverGroup.org
ipd access criteria: The steering and management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision.
ipd url: https://livergroup.org/?q=protocol_full_version
provided document: 