<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/NCT01712971</url>
  </required_header>
  <id_info>
    <org_study_id>LPD</org_study_id>
    <nct_id>NCT01712971</nct_id>
  </id_info>
  <brief_title>Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery</brief_title>
  <official_title>Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baki Topal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gasthuisberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or&#xD;
      peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an&#xD;
      important factor that determines the occurrence of postoperative complications. Therefore,&#xD;
      any significant reduction of intra-operative blood loss will benefit the peri-operative&#xD;
      course.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from&#xD;
      pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD).&#xD;
      With advancing technology, data from expert centers suggest minimally invasive or&#xD;
      laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show&#xD;
      the clinical benefits of LPD vs. OPD.&#xD;
&#xD;
      Advantages of minimally invasive surgery over open surgery are reduced tissue damage,&#xD;
      surgical trauma and immunosuppression.&#xD;
&#xD;
      The general objective of this study is to compare the intra-operative efficacy of LPD vs.&#xD;
      OPD, and in particular the amount of intra-operative blood loss.&#xD;
&#xD;
      Study design Monocentric randomized trial to compare the amount of intra-operative blood loss&#xD;
      in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any&#xD;
      simultaneous other type of surgery will be excluded from the study.&#xD;
&#xD;
      Two experienced surgeons will perform all procedures; RA will perform the open and BT the&#xD;
      laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic&#xD;
      end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic&#xD;
      gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed&#xD;
      for the HJS and the PGS, while the GES will be done with endo-staplers.&#xD;
&#xD;
      Statistical considerations Randomization will take place pre-operatively after informed&#xD;
      consent has been obtained. Patients will be randomized into two groups (OPD vs. LPD) using&#xD;
      permuted blocks of size 6. This implies that of each series of 6 consecutive patients, three&#xD;
      patients will be randomized in each group. There are no stratification variables.&#xD;
&#xD;
      Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs.&#xD;
      OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous&#xD;
      other type of surgery will be excluded from the study.&#xD;
&#xD;
      Reference intra-operative blood loss levels are available from 138 patients (June 2009 - June&#xD;
      2012), without portal vein resection and without additional surgery. Analysis of these data&#xD;
      reveals that these values follow a lognormal distribution; the log-transformed blood loss has&#xD;
      a normal distribution with mean and standard deviation equal to 6.06 and 0.83, respectively.&#xD;
      The corresponding geometric mean equals 427ml. Based on this distribution, 42.4%, 24.7% and&#xD;
      15.1% of the subjects are expected to have blood loss higher than 500, 750 and 1000 ml,&#xD;
      respectively. It is assumed that the treatment (LPD) will lead to a 50% reduction of the&#xD;
      (geometric) mean. The impact of this assumption on the distribution of the blood loss levels&#xD;
      implies that 15.1%, 6.4% and 3.1% of the subjects in the LPD-group are expected to have a&#xD;
      blood loss level higher than 500, 750 and 1000 ml, respectively.&#xD;
&#xD;
      Based on a two-sided two-sample pooled t-test of a mean ratio with lognormal data, a total of&#xD;
      50 subjects is needed to detect a two-fold reduction in blood loss (with alpha set at 5%)&#xD;
      with 90% power.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>intra-operative blood loss</measure>
    <time_frame>day 0 (at the end of surgery)</time_frame>
    <description>the amount of intra-operative blood loss (ml) at the end of surgery (d0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical resection margin</measure>
    <time_frame>day 30</time_frame>
    <description>Histopathological examination of surgical resection margins of the resection specimen; done within 30 days after surgery pR0: tumour-free resection margins pR1: tumour involvement of surgical resection margins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay after surgery</measure>
    <time_frame>day 30; 60; 90; 180</time_frame>
    <description>discharge from hospital after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital costs</measure>
    <time_frame>year 1 &amp; 2</time_frame>
    <description>final cost analysis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Surgery</condition>
  <condition>Pancreatic Tumour</condition>
  <condition>Peri-ampullary Tumour</condition>
  <condition>Blood Loss</condition>
  <arm_group>
    <arm_group_label>OPD</arm_group_label>
    <description>standard open pancreaticoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LPD</arm_group_label>
    <description>laparoscopic pancreaticoduodenectomy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from pancreatic or peri-ampullary tumour&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor&#xD;
&#xD;
          -  Age between 18 to 80 years&#xD;
&#xD;
          -  Patients with and without pre-operative biliary drainage (for obstructive jaundice)&#xD;
&#xD;
          -  Pre-operative radiotherapy, chemotherapy, or biological is allowed&#xD;
&#xD;
          -  PD for IPMN is allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned concomitant surgical procedures such as simultaneous colonic resection etc.&#xD;
&#xD;
          -  Expected/planned reconstruction of the portal vein or superior mesenteric vein&#xD;
&#xD;
          -  Any arterial reconstruction at the time of surgery&#xD;
&#xD;
          -  Age &lt; 18years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  PD for chronic pancreatitis&#xD;
&#xD;
          -  PD for pancreatic trauma&#xD;
&#xD;
          -  PD for post-ERCP complications&#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_official>
    <last_name>Baki Topal, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>September 16, 2013</last_update_submitted>
  <last_update_submitted_qc>September 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gasthuisberg</investigator_affiliation>
    <investigator_full_name>Baki Topal</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>surgery</keyword>
  <keyword>pancreas</keyword>
  <keyword>tumour</keyword>
  <keyword>blood loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Hemorrhage</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/NCT01712971
org study id: LPD
nct id: NCT01712971
lead sponsor: 
has dmc: No
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or
      peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an
      important factor that determines the occurrence of postoperative complications. Therefore,
      any significant reduction of intra-operative blood loss will benefit the peri-operative
      course.
Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from
      pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD).
      With advancing technology, data from expert centers suggest minimally invasive or
      laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show
      the clinical benefits of LPD vs. OPD.

      Advantages of minimally invasive surgery over open surgery are reduced tissue damage,
      surgical trauma and immunosuppression.

      The general objective of this study is to compare the intra-operative efficacy of LPD vs.
      OPD, and in particular the amount of intra-operative blood loss.

      Study design Monocentric randomized trial to compare the amount of intra-operative blood loss
      in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any
      simultaneous other type of surgery will be excluded from the study.

      Two experienced surgeons will perform all procedures; RA will perform the open and BT the
      laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic
      end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic
      gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed
      for the HJS and the PGS, while the GES will be done with endo-staplers.

      Statistical considerations Randomization will take place pre-operatively after informed
      consent has been obtained. Patients will be randomized into two groups (OPD vs. LPD) using
      permuted blocks of size 6. This implies that of each series of 6 consecutive patients, three
      patients will be randomized in each group. There are no stratification variables.

      Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs.
      OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous
      other type of surgery will be excluded from the study.

      Reference intra-operative blood loss levels are available from 138 patients (June 2009 - June
      2012), without portal vein resection and without additional surgery. Analysis of these data
      reveals that these values follow a lognormal distribution; the log-transformed blood loss has
      a normal distribution with mean and standard deviation equal to 6.06 and 0.83, respectively.
      The corresponding geometric mean equals 427ml. Based on this distribution, 42.4%, 24.7% and
      15.1% of the subjects are expected to have blood loss higher than 500, 750 and 1000 ml,
      respectively. It is assumed that the treatment (LPD) will lead to a 50% reduction of the
      (geometric) mean. The impact of this assumption on the distribution of the blood loss levels
      implies that 15.1%, 6.4% and 3.1% of the subjects in the LPD-group are expected to have a
      blood loss level higher than 500, 750 and 1000 ml, respectively.

      Based on a two-sided two-sample pooled t-test of a mean ratio with lognormal data, a total of
      50 subjects is needed to detect a two-fold reduction in blood loss (with alpha set at 5%)
      with 90% power.
observational model: Case-Control
time perspective: Prospective
measure: intra-operative blood loss
time frame: day 0 (at the end of surgery)
description: the amount of intra-operative blood loss (ml) at the end of surgery (d0)
measure: Surgical resection margin
time frame: day 30
description: Histopathological examination of surgical resection margins of the resection specimen; done within 30 days after surgery pR0: tumour-free resection margins pR1: tumour involvement of surgical resection margins
measure: length of hospital stay after surgery
time frame: day 30; 60; 90; 180
description: discharge from hospital after surgery
measure: hospital costs
time frame: year 1 & 2
description: final cost analysis
arm group label: OPD
description: standard open pancreaticoduodenectomy
arm group label: LPD
description: laparoscopic pancreaticoduodenectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Baki Topal, MD, PhD
role: Study Director
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Gasthuisberg
investigator full name: Baki Topal
investigator title: Professor of Surgery
mesh term: Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Hemorrhage