<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/NCT04416685</url>
  </required_header>
  <id_info>
    <org_study_id>PVR-2019</org_study_id>
    <nct_id>NCT04416685</nct_id>
  </id_info>
  <brief_title>A New Anatomical Classification of Portal Vein Location of Pancreas Tumors</brief_title>
  <official_title>A New Anatomical Classification of Portal Venous Involvement in Locally Advanced Pancreatic Cancer to Predict the Surgical Difficulty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      In this retrospective study, we recorded the location of pancreatic tumors and&#xD;
      relation/proximity to the portal vein. The surgical difficulty and requirement of additional&#xD;
      interventions were also evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between May 2014 and October 2018, all patients who underwent PD procedure were&#xD;
      retrospectively reviewed. This retrospective cohort study identified all consecutive patients&#xD;
      with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent&#xD;
      concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were&#xD;
      not responded to neoadjuvant therapy were excluded. The local ethical committee was approved&#xD;
      this study.&#xD;
&#xD;
      Data collection included demographical features, tumor characteristics including the PV level&#xD;
      of the tumor considering computed tomography results, neoadjuvant therapy, surgical data,&#xD;
      hospital stay, morbidity and mortality.&#xD;
&#xD;
      Anatomical classification was established based on the relationship between portal confluence&#xD;
      (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified&#xD;
      as Level I, whereas tumors on the confluence inferiorly located to PC were classified as&#xD;
      Level II and Level III.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location . Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peri-operative or postoperative complication</measure>
    <time_frame>up to one month</time_frame>
    <description>surgical complications observed during both operative and postoperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>up to one month</time_frame>
    <description>the time between the day of surgery and hospital discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>in hospital mortality</measure>
    <time_frame>up to two months</time_frame>
    <description>any mortality after/during surgery in the initial hospital stay</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Pancreatic Neoplasm Malignant Head Primary</condition>
  <arm_group>
    <arm_group_label>Level 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Those tumors located superior to the portal confluence were classified as Level I,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Level II</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>those tumors located on the confluence (involving the confluence) located on the portal confluence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Level III</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>those tumors located inferior to the portal confluence</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>primary repair</intervention_name>
    <description>For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.</description>
    <arm_group_label>Level 1</arm_group_label>
    <arm_group_label>Level II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>segmental resection</intervention_name>
    <description>For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.</description>
    <arm_group_label>Level 1</arm_group_label>
    <arm_group_label>Level II</arm_group_label>
    <arm_group_label>Level III</arm_group_label>
    <other_name>primary repair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>graft reconstruction</intervention_name>
    <description>Regarding Level III tumors, complete resection of the tumor was done either by tangential excision or by partial venous excision and subsequent reconstruction. To maintain a secure anastomosis, the mesenteric root was mobilized completely or/and splenic vein was divided.</description>
    <arm_group_label>Level III</arm_group_label>
    <other_name>segmental resection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This retrospective cohort study identified all consecutive patients with T3 (stage IIA&#xD;
             to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous&#xD;
             (PV/SMV) resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those patients with locally advanced tumors that were not responded to neoadjuvant&#xD;
             therapy were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pinar Yazici</investigator_full_name>
    <investigator_title>Assoc Prof</investigator_title>
  </responsible_party>
  <keyword>pancreas tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>any question about details can be shared via e-mail privately.</ipd_description>
  </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/NCT04416685
org study id: PVR-2019
nct id: NCT04416685
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this retrospective study, we recorded the location of pancreatic tumors and
      relation/proximity to the portal vein. The surgical difficulty and requirement of additional
      interventions were also evaluated.
Between May 2014 and October 2018, all patients who underwent PD procedure were
      retrospectively reviewed. This retrospective cohort study identified all consecutive patients
      with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent
      concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were
      not responded to neoadjuvant therapy were excluded. The local ethical committee was approved
      this study.

      Data collection included demographical features, tumor characteristics including the PV level
      of the tumor considering computed tomography results, neoadjuvant therapy, surgical data,
      hospital stay, morbidity and mortality.

      Anatomical classification was established based on the relationship between portal confluence
      (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified
      as Level I, whereas tumors on the confluence inferiorly located to PC were classified as
      Level II and Level III.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location . Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.
primary purpose: Treatment
masking: None (Open Label)
measure: peri-operative or postoperative complication
time frame: up to one month
description: surgical complications observed during both operative and postoperative period
measure: hospital stay
time frame: up to one month
description: the time between the day of surgery and hospital discharge
measure: in hospital mortality
time frame: up to two months
description: any mortality after/during surgery in the initial hospital stay
arm group label: Level 1
arm group type: Other
description: Those tumors located superior to the portal confluence were classified as Level I,
arm group label: Level II
arm group type: Other
description: those tumors located on the confluence (involving the confluence) located on the portal confluence
arm group label: Level III
arm group type: Other
description: those tumors located inferior to the portal confluence
intervention type: Procedure
intervention name: primary repair
description: For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
arm group label: Level 1
arm group label: Level II
intervention type: Procedure
intervention name: segmental resection
description: For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
arm group label: Level 1
arm group label: Level II
arm group label: Level III
other name: primary repair
intervention type: Procedure
intervention name: graft reconstruction
description: Regarding Level III tumors, complete resection of the tumor was done either by tangential excision or by partial venous excision and subsequent reconstruction. To maintain a secure anastomosis, the mesenteric root was mobilized completely or/and splenic vein was divided.
arm group label: Level III
other name: segmental resection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Pinar Yazici
investigator title: Assoc Prof
mesh term: Pancreatic Neoplasms
mesh term: Neoplasms
sharing ipd: Undecided
ipd description: any question about details can be shared via e-mail privately.