<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/NCT02203409</url>
  </required_header>
  <id_info>
    <org_study_id>SWHZSG005</org_study_id>
    <secondary_id>30972948</secondary_id>
    <nct_id>NCT02203409</nct_id>
  </id_info>
  <brief_title>Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy</brief_title>
  <official_title>Laparoscopic Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shuguo Zheng, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southwest Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a&#xD;
      single center. The validity, feasibility and limitations were assessed objectively through&#xD;
      our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective&#xD;
      and feasible.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Associating liver partition and portal vein ligation for staged hepatectomy&#xD;
      (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which&#xD;
      stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published&#xD;
      literature reported that the two stages of ALPPS are the conventional laparotomy&#xD;
      surgery，Patients need to undergo the injury of two open operations in a short time. The&#xD;
      incidence of postoperative complications and mortality rate is as high as 53% -73% and&#xD;
      12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure&#xD;
      in a single center, with special emphasis in validity, feasibility and limitations.&#xD;
&#xD;
      Results:&#xD;
&#xD;
      Clinical data include: operation time, intraoperative blood loss, volume of blood&#xD;
      transfusion, complications and mortality, postoperative liver function, long-term curative&#xD;
      effect and survival time were collected and analysed.&#xD;
&#xD;
      Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression&#xD;
      analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival&#xD;
      analysis，Log-rank survival curves were used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of the procedure defined as the incidence of postoperative complications and mortality</measure>
    <time_frame>within the first 90 days after the first stage</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival rate</measure>
    <time_frame>3 years</time_frame>
    <description>follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Tumor</condition>
  <arm_group>
    <arm_group_label>Laparoscopic ALPPS group</arm_group_label>
    <description>Patients with small future liver remnant who are operated with the &quot;Associating Liver Partition and Portal vein ligation for Staged hepatectomy&quot; approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic ALPPS</intervention_name>
    <description>Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy</description>
    <arm_group_label>Laparoscopic ALPPS group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        30&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with marginally resectable or primarily non-resectable locally advanced liver&#xD;
             tumors&#xD;
&#xD;
          -  Insufficient future liver remnant (FLR) either in volume or quality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unresectable liver metastases in the future liver remnant or unresectable extrahepatic&#xD;
             metastases&#xD;
&#xD;
          -  Severe portal hypertension&#xD;
&#xD;
          -  High anesthesiological risk&#xD;
&#xD;
          -  Unresectable primary tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuguo Zheng</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuguo Zheng</last_name>
    <phone>86-13508308676</phone>
    <email>shuguozh@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuguo Zheng, Professor</last_name>
      <phone>86-13508308676</phone>
      <email>shuguozh@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gruttadauria S, Vasta F, Minervini MI, Piazza T, Arcadipane A, Marcos A, Gridelli B. Significance of the effective remnant liver volume in major hepatectomies. Am Surg. 2005 Mar;71(3):235-40.</citation>
    <PMID>15869140</PMID>
  </reference>
  <reference>
    <citation>Barbaro B, Caputo F, Tebala C, Di Stasi C, Vellone M, Giuliante F, Nuzzo G, Bonomo L. Preoperative right portal vein embolisation: indications and results. Radiol Med. 2009 Jun;114(4):553-70. doi: 10.1007/s11547-009-0383-9. Epub 2009 Apr 13. English, Italian.</citation>
    <PMID>19367466</PMID>
  </reference>
  <reference>
    <citation>de Baere T, Denys A, Madoff DC. Preoperative portal vein embolization: indications and technical considerations. Tech Vasc Interv Radiol. 2007 Mar;10(1):67-78. doi: 10.1053/j.tvir.2007.08.003.</citation>
    <PMID>17980321</PMID>
  </reference>
  <reference>
    <citation>Alvarez FA, Ardiles V, Sanchez Claria R, Pekolj J, de Santibanes E. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): tips and tricks. J Gastrointest Surg. 2013 Apr;17(4):814-21. doi: 10.1007/s11605-012-2092-2. Epub 2012 Nov 27.</citation>
    <PMID>23188224</PMID>
  </reference>
  <reference>
    <citation>Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.</citation>
    <PMID>22330038</PMID>
  </reference>
  <reference>
    <citation>Sala S, Ardiles V, Ulla M, Alvarez F, Pekolj J, de Santibanes E. Our initial experience with ALPPS technique: encouraging results. Updates Surg. 2012 Sep;64(3):167-72. doi: 10.1007/s13304-012-0175-y. Epub 2012 Aug 18.</citation>
    <PMID>22903531</PMID>
  </reference>
  <reference>
    <citation>Li J, Girotti P, Konigsrainer I, Ladurner R, Konigsrainer A, Nadalin S. ALPPS in right trisectionectomy: a safe procedure to avoid postoperative liver failure? J Gastrointest Surg. 2013 May;17(5):956-61. doi: 10.1007/s11605-012-2132-y. Epub 2013 Jan 4.</citation>
    <PMID>23288719</PMID>
  </reference>
  <reference>
    <citation>Dokmak S, Belghiti J. Which limits to the &quot;ALPPS&quot; approach? Ann Surg. 2012 Sep;256(3):e6; author reply e16-7. doi: 10.1097/SLA.0b013e318265fd64. No abstract available.</citation>
    <PMID>22895355</PMID>
  </reference>
  <reference>
    <citation>Toyosaka A, Okamoto E, Mitsunobu M, Oriyama T, Nakao N, Miura K. Intrahepatic metastases in hepatocellular carcinoma: evidence for spread via the portal vein as an efferent vessel. Am J Gastroenterol. 1996 Aug;91(8):1610-5.</citation>
    <PMID>8759671</PMID>
  </reference>
  <reference>
    <citation>Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26.</citation>
    <PMID>23099728</PMID>
  </reference>
  <reference>
    <citation>Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.</citation>
    <PMID>11420484</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Southwest Hospital, China</investigator_affiliation>
    <investigator_full_name>Shuguo Zheng, MD</investigator_full_name>
    <investigator_title>Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department</investigator_title>
  </responsible_party>
  <keyword>liver tumor</keyword>
  <keyword>Two stage hepatectomy</keyword>
  <keyword>Hypertrophy</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>ALPPS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02203409
org study id: SWHZSG005
secondary id: 30972948
nct id: NCT02203409
lead sponsor: 
has dmc: Yes
The purpose of this research is evaluate the results with laparoscopic ALPPS procedure in a
      single center. The validity, feasibility and limitations were assessed objectively through
      our clinical prospective study.The investigators expect laparoscopic ALPPS is safe, effective
      and feasible.
Background: Associating liver partition and portal vein ligation for staged hepatectomy
      (ALPPS) is a breakthrough in the field of hepatobiliary surgery in recent years，which
      stimulates the remnant liver volume(RLV) grew by 74%-87.2% in 9 to 13 days。The published
      literature reported that the two stages of ALPPS are the conventional laparotomy
      surgery，Patients need to undergo the injury of two open operations in a short time. The
      incidence of postoperative complications and mortality rate is as high as 53% -73% and
      12%-27%.The aim of this study was to evaluate the results with laparoscopic ALPPS procedure
      in a single center, with special emphasis in validity, feasibility and limitations.

      Results:

      Clinical data include: operation time, intraoperative blood loss, volume of blood
      transfusion, complications and mortality, postoperative liver function, long-term curative
      effect and survival time were collected and analysed.

      Statistical method:groups t-test ，univariate/multivariate analysis, logistic regression
      analysis, mixed linear regression, Cox survival analysis ，Kaplan-Meier survival
      analysis，Log-rank survival curves were used.
observational model: Cohort
time perspective: Prospective
measure: Safety of the procedure defined as the incidence of postoperative complications and mortality
time frame: within the first 90 days after the first stage
measure: survival rate
time frame: 3 years
description: follow-up after the surgery every 3months, to understand relapse, death, statistics 1-year, 3-year overall survival rates，disease-free survival rates , recurrence and metastasis rate.
arm group label: Laparoscopic ALPPS group
description: Patients with small future liver remnant who are operated with the "Associating Liver Partition and Portal vein ligation for Staged hepatectomy" approach
intervention type: Procedure
intervention name: Laparoscopic ALPPS
description: Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy
arm group label: Laparoscopic ALPPS group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shuguo Zheng
role: Study Director
affiliation: Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
last name: Shuguo Zheng
phone: 86-13508308676
email: shuguozh@gmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Gruttadauria S, Vasta F, Minervini MI, Piazza T, Arcadipane A, Marcos A, Gridelli B. Significance of the effective remnant liver volume in major hepatectomies. Am Surg. 2005 Mar;71(3):235-40.
PMID: 15869140
citation: Barbaro B, Caputo F, Tebala C, Di Stasi C, Vellone M, Giuliante F, Nuzzo G, Bonomo L. Preoperative right portal vein embolisation: indications and results. Radiol Med. 2009 Jun;114(4):553-70. doi: 10.1007/s11547-009-0383-9. Epub 2009 Apr 13. English, Italian.
PMID: 19367466
citation: de Baere T, Denys A, Madoff DC. Preoperative portal vein embolization: indications and technical considerations. Tech Vasc Interv Radiol. 2007 Mar;10(1):67-78. doi: 10.1053/j.tvir.2007.08.003.
PMID: 17980321
citation: Alvarez FA, Ardiles V, Sanchez Claria R, Pekolj J, de Santibanes E. Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS): tips and tricks. J Gastrointest Surg. 2013 Apr;17(4):814-21. doi: 10.1007/s11605-012-2092-2. Epub 2012 Nov 27.
PMID: 23188224
citation: Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.
PMID: 22330038
citation: Sala S, Ardiles V, Ulla M, Alvarez F, Pekolj J, de Santibanes E. Our initial experience with ALPPS technique: encouraging results. Updates Surg. 2012 Sep;64(3):167-72. doi: 10.1007/s13304-012-0175-y. Epub 2012 Aug 18.
PMID: 22903531
citation: Li J, Girotti P, Konigsrainer I, Ladurner R, Konigsrainer A, Nadalin S. ALPPS in right trisectionectomy: a safe procedure to avoid postoperative liver failure? J Gastrointest Surg. 2013 May;17(5):956-61. doi: 10.1007/s11605-012-2132-y. Epub 2013 Jan 4.
PMID: 23288719
citation: Dokmak S, Belghiti J. Which limits to the "ALPPS" approach? Ann Surg. 2012 Sep;256(3):e6; author reply e16-7. doi: 10.1097/SLA.0b013e318265fd64. No abstract available.
PMID: 22895355
citation: Toyosaka A, Okamoto E, Mitsunobu M, Oriyama T, Nakao N, Miura K. Intrahepatic metastases in hepatocellular carcinoma: evidence for spread via the portal vein as an efferent vessel. Am J Gastroenterol. 1996 Aug;91(8):1610-5.
PMID: 8759671
citation: Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013 Apr;20(4):1203-15. doi: 10.1245/s10434-012-2705-8. Epub 2012 Oct 26.
PMID: 23099728
citation: Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010.
PMID: 11420484
responsible party type: Sponsor-Investigator
investigator affiliation: Southwest Hospital, China
investigator full name: Shuguo Zheng, MD
investigator title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
mesh term: Liver Neoplasms