<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/NCT03010085</url>
  </required_header>
  <id_info>
    <org_study_id>OLLEH trial</org_study_id>
    <nct_id>NCT03010085</nct_id>
  </id_info>
  <brief_title>Open Versus Laparoscopic Left-sided Hepatectomy Trial</brief_title>
  <acronym>OLLEH</acronym>
  <official_title>A Multicenter Randomized Controlled Trial of Open Versus Laparoscopic Left-sided Hepatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ewha Womans University Mokdong Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Cancer Center Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul National University Boramae Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eulji University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bucheon St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gyeongsang National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jeju National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hallym University Kangnam Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ewha Womans University Mokdong Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional,&#xD;
      prospective and randomized trial in patients undergoing left sided hepatectomy through&#xD;
      laparoscopic versus open procedure.&#xD;
&#xD;
      Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood&#xD;
      loss, operation time, resection margin status, postoperative complication, mortality, liver&#xD;
      function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic&#xD;
      neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and&#xD;
      effective compared with open conventional left-sided hemihepatectomy. However, prospective&#xD;
      study is rare and there is no randomized controlled trial.&#xD;
&#xD;
      The surgeons who are affiliated at a medical center in capital area of Korea launched the&#xD;
      Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome&#xD;
      of laparoscopic left-sided hepatectomy.&#xD;
&#xD;
      Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study&#xD;
      is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional&#xD;
      recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Checklist of functional recovery&#xD;
(Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No)&#xD;
(Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No)&#xD;
(Questionnaire) Do you have trouble to digest solid meal ? (Yes, No)&#xD;
(Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No)&#xD;
(Liver function test) Are serum aspartate aminotransferase and alanine aminotransferase increasing ? (Yes, No)&#xD;
Daily check the five item above until every item is 'No'&#xD;
If all of the items are 'No', the patient is regarded as a functionally recovered state.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Discharge summary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Death within 30 days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital duration</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Hospital duration after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Estimated blood loss on anesthesiology sheet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation time</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Skin incision to wound closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection margin status</measure>
    <time_frame>up to 30 days</time_frame>
    <description>According to the pathology report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function test</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>up to 30 days</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Neoplasm, Liver</condition>
  <arm_group>
    <arm_group_label>A (Open left-sided hepatectomy)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (Laparoscopic left-sided hepatectomy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open left-sided hepatectomy</intervention_name>
    <description>Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy</description>
    <arm_group_label>A (Open left-sided hepatectomy)</arm_group_label>
    <other_name>Left-sided hepatectomy</other_name>
    <other_name>Left lateral sectionectomy</other_name>
    <other_name>Left hemihepatectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic left-sided hepatectomy</intervention_name>
    <description>Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy</description>
    <arm_group_label>B (Laparoscopic left-sided hepatectomy)</arm_group_label>
    <other_name>Laparoscopic left lateral sectionectomy</other_name>
    <other_name>Laparoscopic left hemihepatectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient who underwent open or laparoscopic left-sided hepatectomy for benign or&#xD;
             malignant neoplasm of the liver&#xD;
&#xD;
          2. Child-Pugh A without portal hypertension&#xD;
&#xD;
               -  No portosystemic shunt&#xD;
&#xD;
               -  No splenomegaly&#xD;
&#xD;
               -  Platelet count &gt;100,000/ul&#xD;
&#xD;
          3. Age 18 to 80&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status: 0 or 1&#xD;
&#xD;
          5. American society of anesthesiology class: I or II&#xD;
&#xD;
          6. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol.&#xD;
             Injection Therapy or others)&#xD;
&#xD;
          2. Combined hepatectomy&#xD;
&#xD;
          3. Bile duct reconstruction&#xD;
&#xD;
          4. Intrahepatic duct stone&#xD;
&#xD;
          5. Upper abdominal laparotomy history&#xD;
&#xD;
          6. Previous hepatectomy&#xD;
&#xD;
          7. Combined operation for extrahepatic disease&#xD;
&#xD;
          8. Vulnerable population (mental retardation, pregnancy)&#xD;
&#xD;
          9. Patient who participated in other clinical trial within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seung Duk Lee, MD</last_name>
    <phone>+82-31-920-1709</phone>
    <email>mmcleemed@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunsung Seo, MS</last_name>
    <phone>+82-31-920-0745</phone>
    <email>73872@ncc.re.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07985</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Huisong Lee, MD</last_name>
      <phone>+82-2-2650-6153</phone>
      <email>huisong.lee@ewha.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ewha Womans University Mokdong Hospital</investigator_affiliation>
    <investigator_full_name>Huisong Lee</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_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/NCT03010085
org study id: OLLEH trial
nct id: NCT03010085
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial Multi-institutional,
      prospective and randomized trial in patients undergoing left sided hepatectomy through
      laparoscopic versus open procedure.

      Primary endpoint: Functional recovery Secondary endpoint: Hospital duration, estimated blood
      loss, operation time, resection margin status, postoperative complication, mortality, liver
      function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness
Laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic
      neoplasms. Many studies have reported that laparoscopic left-sided hepatectomy is safe and
      effective compared with open conventional left-sided hemihepatectomy. However, prospective
      study is rare and there is no randomized controlled trial.

      The surgeons who are affiliated at a medical center in capital area of Korea launched the
      Open versus Laparoscopic Left-sided Hepatectomy (OLLEH) trial to verify the surgical outcome
      of laparoscopic left-sided hepatectomy.

      Laparoscopic surgery has benefits that less wound and less pain. The hypothesis of the study
      is 'The laparoscopic left-sided hemihepatectomy is better than open surgery from functional
      recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Checklist of functional recovery (Questionnaire, liver function test of aspartate aminotransferase and alanine aminotransferase)
time frame: up to 30 days
description: Checklist of functional recovery
(Questionnaire) Do you want intravenous analgesics for postoperative pain ? (Yes, No)
(Questionnaire) Do you have trouble to ambulate by oneself ? (Yes, No)
(Questionnaire) Do you have trouble to digest solid meal ? (Yes, No)
(Questionnaire) Do you want intravenous fluid to subside your thirsty ? (Yes, No)
(Liver function test) Are serum aspartate aminotransferase and alanine aminotransferase increasing ? (Yes, No)
Daily check the five item above until every item is 'No'
If all of the items are 'No', the patient is regarded as a functionally recovered state.
measure: Postoperative complication
time frame: up to 30 days
description: Discharge summary
measure: Mortality
time frame: up to 30 days
description: Death within 30 days after surgery
measure: Readmission rate
time frame: up to 30 days
description: Readmission
measure: Hospital duration
time frame: up to 30 days
description: Hospital duration after surgery
measure: Blood loss
time frame: up to 30 days
description: Estimated blood loss on anesthesiology sheet
measure: Operation time
time frame: up to 30 days
description: Skin incision to wound closure
measure: Resection margin status
time frame: up to 30 days
description: According to the pathology report
measure: Liver function test
time frame: up to 30 days
description: Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Prothrombin time, international normalized ratio (INR), Albumin
measure: Quality of life
time frame: up to 30 days
description: questionnaire
arm group label: A (Open left-sided hepatectomy)
arm group type: Active Comparator
description: Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
arm group label: B (Laparoscopic left-sided hepatectomy)
arm group type: Experimental
description: Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
intervention type: Procedure
intervention name: Open left-sided hepatectomy
description: Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
arm group label: A (Open left-sided hepatectomy)
other name: Left-sided hepatectomy
other name: Left lateral sectionectomy
other name: Left hemihepatectomy
intervention type: Procedure
intervention name: Laparoscopic left-sided hepatectomy
description: Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
arm group label: B (Laparoscopic left-sided hepatectomy)
other name: Laparoscopic left lateral sectionectomy
other name: Laparoscopic left hemihepatectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Seung Duk Lee, MD
phone: +82-31-920-1709
email: mmcleemed@gmail.com
last name: Yunsung Seo, MS
phone: +82-31-920-0745
email: 73872@ncc.re.kr
facility: 
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ewha Womans University Mokdong Hospital
investigator full name: Huisong Lee
investigator title: Dr.
mesh term: Liver Neoplasms
sharing ipd: No