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/NCT05975710</url>
    </required_header>
    <id_info>
      <org_study_id>KMIPS</org_study_id>
      <nct_id>NCT05975710</nct_id>
    </id_info>
    <brief_title>Textbook and Survival Outcomes of MIPD in South Korea</brief_title>
    <official_title>Textbook and Survival Outcomes of Minimally Invasive Pancreatoduodenectomy : A Retrospective Multicenter Analysis of 1,552 Patients in Korean Study Group on Minimally Invasive Pancreatic Surgery (K-MIPS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Asan Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Asan Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study was to investigate the current status of minimally invasive&#xD;
        pancreatoduodenectomy (MIPD) in South Korea with regard to demographics, perioperative&#xD;
        outcomes, risk factors for textbook outcome of pancreatic surgery (TOPS) and survival&#xD;
        outcomes of periampullary cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatoduodenectomy (PD) is the most complicated abdominal surgical procedure and in&#xD;
        addition, the difficulty of this operation is much higher if it is performed using minimally&#xD;
        invasive methods. Since these first minimally invasive pancreatoduodenectomy (MIPD) surgeries&#xD;
        were performed, they have been adopted by various institutions and their effectiveness has&#xD;
        been highlighted in several studies. Advantages of MIPD include a short hospital stay, less&#xD;
        blood loss, and less pain compared to open procedures. However, a multicenter randomized&#xD;
        controlled trial that compared LPD and open pancreatoduodenectomy (OPD) reported that LPD had&#xD;
        a higher complication-related mortality rate than OPD. Meta-analysis of randomized controlled&#xD;
        trials of LPD versus OPD also reported that LPD had no advantage over OPD but with a high&#xD;
        risk of bias and moderate to low level of evidence. In a meta-analysis of RPD and OPD, RPD&#xD;
        was found to have the advantages of less blood loss, shorter hospital stay, and lower wound&#xD;
        infection rate than OPD, but to date, no studies have reported results for randomized&#xD;
        controlled trials of RPD. Although it is still early to make generalized conclusions about&#xD;
        MIPD due to the selection bias inherent in retrospective studies and an insufficient number&#xD;
        of prospective studies, the frequency with which MIPD is being performed is gradually&#xD;
        increasing. Studies on the learning curve of MIPD are currently in progress, and one study&#xD;
        recommended establishment of an MIPD registry for research purposes. South Korea is one of&#xD;
        the country leading the implementation of MIPD, and several Korean groups have published&#xD;
        studies on this surgery and have collaborated to establish a registry in line with global&#xD;
        trends. After the establishment of the Korean study group on Minimally Invasive Pancreatic&#xD;
        Surgery (K-MIPS) in 2019 (http://kmips.or.kr/index.html), 1,552 MIPD patients were&#xD;
        retrospectively enrolled. Apart from this, the textbook outcomes after surgery was recently&#xD;
        emerged as a valuable approach for assessing surgical success, as it considers multiple&#xD;
        quality measures to provide a comprehensive indication of overall outcomes. Recently, the&#xD;
        Dutch Pancreatic Cancer Group reported about textbook outcome of pancreatic surgery (TOPS),&#xD;
        which is also a multidimensional measure that allows assessment of the quality of surgical&#xD;
        outcomes, and several papers have investigated textbook outcome after hepatobiliary and&#xD;
        pancreatic surgery. From this perspective, conducting an analysis of the current status of&#xD;
        MIPD in Korea and evaluating the surgical outcomes by TOPS would provide valuable insights,&#xD;
        making this study highly relevant and meaningful. The aim of this study was to describe the&#xD;
        current status of MIPD in South Korea in terms of demographics, perioperative outcomes,&#xD;
        survival outcomes, TOPS and risk factor of TOPS. In addition, current study compared&#xD;
        subgroups classified according to hospital volume in South Korea to determine if hospital&#xD;
        volume affects perioperative outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2020</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</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>Success rate of textbook outcome of pancreatic surgery</measure>
      <time_frame>3 months</time_frame>
      <description>If none of the seven specified factors (1. postoperative pancreatic fistula, 2. bile leakage, 3. postpancreatectomy hemorrhage, 4. Clavien-Dindo 3 or higher of complications, 5. readmission within 90 days, 6. in-hospital or 90-day mortality, 7. postoperative hospital stay of more than 14 days) occur after minimally invasive pancreatoduodenectomy, it is defined as TOPS success in current study.&#xD;
  In other words, a patient's outcome is considered successful if they do not experience any of these adverse events or complications within the specified time frames.</description>
    </primary_outcome>
    <enrollment type="Actual">1552</enrollment>
    <condition>Surgery-Complications</condition>
    <eligibility>
      <study_pop>
        <textblock>
          This retrospective multicenter cohort study evaluated 1,552 patients who underwent MIPD by&#xD;
          24 experienced pancreatic surgeons between May 2007 and April 2020 at ten tertiary referral&#xD;
          institutions in South Korea. The research was conducted using data registered in the&#xD;
          registry of the Korean study group on Minimally Invasive Pancreatic Surgery (K-MIPS). The&#xD;
          consecutive patient's data were recorded retrospectively and self-registered at each&#xD;
          institution.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The patients who underwent MIPD between May 2007 and April 2020 at ten tertiary referral&#xD;
          institutions in South Korea.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Song Cheol Kim, MD.PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Asan Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Asan medical center</name>
        <address>
          <city>Seoul</city>
          <zip>05505</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Asan Medical Center</investigator_affiliation>
      <investigator_full_name>Song Cheol Kim</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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/NCT05975710
  org study id: KMIPS
  nct id: NCT05975710
  lead sponsor: 
  has dmc: No
  The aim of this study was to investigate the current status of minimally invasive
        pancreatoduodenectomy (MIPD) in South Korea with regard to demographics, perioperative
        outcomes, risk factors for textbook outcome of pancreatic surgery (TOPS) and survival
        outcomes of periampullary cancer.
  Pancreatoduodenectomy (PD) is the most complicated abdominal surgical procedure and in
        addition, the difficulty of this operation is much higher if it is performed using minimally
        invasive methods. Since these first minimally invasive pancreatoduodenectomy (MIPD) surgeries
        were performed, they have been adopted by various institutions and their effectiveness has
        been highlighted in several studies. Advantages of MIPD include a short hospital stay, less
        blood loss, and less pain compared to open procedures. However, a multicenter randomized
        controlled trial that compared LPD and open pancreatoduodenectomy (OPD) reported that LPD had
        a higher complication-related mortality rate than OPD. Meta-analysis of randomized controlled
        trials of LPD versus OPD also reported that LPD had no advantage over OPD but with a high
        risk of bias and moderate to low level of evidence. In a meta-analysis of RPD and OPD, RPD
        was found to have the advantages of less blood loss, shorter hospital stay, and lower wound
        infection rate than OPD, but to date, no studies have reported results for randomized
        controlled trials of RPD. Although it is still early to make generalized conclusions about
        MIPD due to the selection bias inherent in retrospective studies and an insufficient number
        of prospective studies, the frequency with which MIPD is being performed is gradually
        increasing. Studies on the learning curve of MIPD are currently in progress, and one study
        recommended establishment of an MIPD registry for research purposes. South Korea is one of
        the country leading the implementation of MIPD, and several Korean groups have published
        studies on this surgery and have collaborated to establish a registry in line with global
        trends. After the establishment of the Korean study group on Minimally Invasive Pancreatic
        Surgery (K-MIPS) in 2019 (http://kmips.or.kr/index.html), 1,552 MIPD patients were
        retrospectively enrolled. Apart from this, the textbook outcomes after surgery was recently
        emerged as a valuable approach for assessing surgical success, as it considers multiple
        quality measures to provide a comprehensive indication of overall outcomes. Recently, the
        Dutch Pancreatic Cancer Group reported about textbook outcome of pancreatic surgery (TOPS),
        which is also a multidimensional measure that allows assessment of the quality of surgical
        outcomes, and several papers have investigated textbook outcome after hepatobiliary and
        pancreatic surgery. From this perspective, conducting an analysis of the current status of
        MIPD in Korea and evaluating the surgical outcomes by TOPS would provide valuable insights,
        making this study highly relevant and meaningful. The aim of this study was to describe the
        current status of MIPD in South Korea in terms of demographics, perioperative outcomes,
        survival outcomes, TOPS and risk factor of TOPS. In addition, current study compared
        subgroups classified according to hospital volume in South Korea to determine if hospital
        volume affects perioperative outcomes.
  observational model: Cohort
  time perspective: Retrospective
  measure: Success rate of textbook outcome of pancreatic surgery
  time frame: 3 months
  description: If none of the seven specified factors (1. postoperative pancreatic fistula, 2. bile leakage, 3. postpancreatectomy hemorrhage, 4. Clavien-Dindo 3 or higher of complications, 5. readmission within 90 days, 6. in-hospital or 90-day mortality, 7. postoperative hospital stay of more than 14 days) occur after minimally invasive pancreatoduodenectomy, it is defined as TOPS success in current study.
  In other words, a patient's outcome is considered successful if they do not experience any of these adverse events or complications within the specified time frames.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Song Cheol Kim, MD.PhD
  role: Principal Investigator
  affiliation: Asan Medical Center
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Asan Medical Center
  investigator full name: Song Cheol Kim
  investigator title: Professor
  sharing ipd: No