<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/NCT03754595</url>
  </required_header>
  <id_info>
    <org_study_id>DaiMH</org_study_id>
    <nct_id>NCT03754595</nct_id>
  </id_info>
  <brief_title>Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial</brief_title>
  <official_title>Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and&#xD;
      radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic&#xD;
      cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to&#xD;
      compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to compare the efficiency and safety between 2D laparoscopic&#xD;
      pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We&#xD;
      design a prospective randomized study. Patients with malignant pancreatic tumor who underwent&#xD;
      pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible&#xD;
      patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the&#xD;
      operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of&#xD;
      surgery, duration of operation and complication rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>60 month</time_frame>
    <description>overall survival duration after surgical treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall complications</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>The proportion of all complications after operation accounted for the total number of patients</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Operative time</measure>
    <time_frame>12 hours</time_frame>
    <description>Durtion of operation</description>
  </other_outcome>
  <other_outcome>
    <measure>Pancreatic fistula</measure>
    <time_frame>Up to postoperative 30 days</time_frame>
    <description>The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pancreatoduodenectomy</condition>
  <arm_group>
    <arm_group_label>2D Laparoscopic pancreatoduodenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D Laparoscopic pancreatoduodenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D Laparoscopic pancreatoduodenectomy</intervention_name>
    <description>Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy</description>
    <arm_group_label>3D Laparoscopic pancreatoduodenectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>2D Laparoscopic pancreatoduodenectomy</intervention_name>
    <description>2D Laparoscopic pancreatoduodenectomy</description>
    <arm_group_label>2D Laparoscopic pancreatoduodenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age: &gt;18yr, &lt;75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct&#xD;
        cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging&#xD;
        assessment is resectable or borderline resectable -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of&#xD;
        SMV was more than 180 degrees, or distant metastasis.&#xD;
&#xD;
        conversion to laparotomy because of intraoperative difficulty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menghua Dai, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical Coll3ge hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cheng Ding, MD</last_name>
    <phone>+861069152601</phone>
    <email>dingcheng13@126.com</email>
  </overall_contact>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>2D and 3D Laparoscopic pancreatoduodenectomy</keyword>
  <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/NCT03754595
org study id: DaiMH
nct id: NCT03754595
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and
      radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic
      cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to
      compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT
      study.
This study is to compare the efficiency and safety between 2D laparoscopic
      pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We
      design a prospective randomized study. Patients with malignant pancreatic tumor who underwent
      pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible
      patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the
      operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of
      surgery, duration of operation and complication rate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 60 month
description: overall survival duration after surgical treatment
measure: Overall complications
time frame: Up to postoperative 30 days
description: The proportion of all complications after operation accounted for the total number of patients
measure: Operative time
time frame: 12 hours
description: Durtion of operation
measure: Pancreatic fistula
time frame: Up to postoperative 30 days
description: The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
arm group label: 2D Laparoscopic pancreatoduodenectomy
arm group type: Active Comparator
description: Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy
arm group label: 3D Laparoscopic pancreatoduodenectomy
arm group type: Experimental
description: Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
intervention type: Procedure
intervention name: 3D Laparoscopic pancreatoduodenectomy
description: Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
arm group label: 3D Laparoscopic pancreatoduodenectomy
intervention type: Procedure
intervention name: 2D Laparoscopic pancreatoduodenectomy
description: 2D Laparoscopic pancreatoduodenectomy
arm group label: 2D Laparoscopic pancreatoduodenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Menghua Dai, MD
role: Study Director
affiliation: Peking Union Medical Coll3ge hospital
last name: Cheng Ding, MD
phone: +861069152601
email: dingcheng13@126.com
responsible party type: Sponsor
sharing ipd: No