<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/NCT02246205</url>
  </required_header>
  <id_info>
    <org_study_id>PAUDA</org_study_id>
    <nct_id>NCT02246205</nct_id>
  </id_info>
  <brief_title>Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)</brief_title>
  <acronym>PAUDA</acronym>
  <official_title>Billroth II or Roux-en-Y Reconstruction for Gastrojejunostomy After Pancreaticoduodenectomy: Randomized Controlled Trial (PAUDA TRIAL): Comparison of Morbidity and Delayed Gastric Emptying</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,&#xD;
      DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for&#xD;
      DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE&#xD;
      after pancreaticoduodenectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the&#xD;
      pancreas, periampullary tumors and intractable inflammatory pathology.&#xD;
&#xD;
      The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery.&#xD;
      The most common complication is delayed gastric emptying (DGE), defined as the intolerance to&#xD;
      solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur&#xD;
      after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and&#xD;
      prolonged hospital stay.&#xD;
&#xD;
      The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,&#xD;
      DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for&#xD;
      DPC.&#xD;
&#xD;
      The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after&#xD;
      pancreaticoduodenectomy.&#xD;
&#xD;
      A pilot randomized clinical trial has been designed to compare two surgical techniques for&#xD;
      reconstruction of digestive tract after DPC in patients treated in our center. The patients&#xD;
      are randomized after tumor resection and before the reconstruction througt computer-generated&#xD;
      random numbers using a sealed envelope technique. The primary endpoint is the incidence of&#xD;
      DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic&#xD;
      fistula, the hospital stay, and postoperative endocrine and exocrine function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delayed gastric emptying incidence after pancreaticoduodenectomy</measure>
    <time_frame>within the first 60 daysafter surgery</time_frame>
    <description>DGE, defined as oral diet intolerance from the 7th postoperative day, and the persistence of nasogastric tube on the 4th postoperative day or later, according to the ISGPS criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity and complications after pancreaticoduodenectomy</measure>
    <time_frame>within the first 60 daysafter surgery</time_frame>
    <description>Postoperative morbidity was defined as any complication that appeared during hospital admission. Postoperative complications and postoperative mortality were defined according to the Clavien-Dindo classification.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Malignant Neoplasm of Head of Pancreas</condition>
  <arm_group>
    <arm_group_label>DPC DN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Roux-en Y reconstruction after pancreaticoduodenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DPC UN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Child reconstruction after pancreaticoduodenectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreaticoduodenectomy</intervention_name>
    <description>Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconstruction techniques.</description>
    <arm_group_label>DPC DN</arm_group_label>
    <arm_group_label>DPC UN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pancreatic head cancer considered resectable after the extension study&#xD;
&#xD;
          -  Patients suffering from periampullary tumors considered resectable after the extension&#xD;
             study&#xD;
&#xD;
          -  Patients suffering from pancreatic inflammatory disease with medically intractable&#xD;
             pain&#xD;
&#xD;
          -  Patients who have read the information sheet of the study and signed the informed&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of previous gastrectomy&#xD;
&#xD;
          -  Patients with associated resections of other organs, except for the superior portal&#xD;
             vein or mesenteric vein&#xD;
&#xD;
          -  Patients with enlargement to total pancreatectomy&#xD;
&#xD;
          -  Patients who has recieved neoadjuvant treatment&#xD;
&#xD;
          -  Patients with plastic peritonitis&#xD;
&#xD;
          -  Patients with liver cirrhosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JULI BUSQUETS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari de Bellvitge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Hospitalet Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>JULI BUSQUETS BARENYS</investigator_full_name>
    <investigator_title>Medicine Doctor</investigator_title>
  </responsible_party>
  <keyword>pancreaticoduodenectomy</keyword>
  <keyword>delayed gastric emptying</keyword>
  <keyword>Roux en-Y reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02246205
org study id: PAUDA
nct id: NCT02246205
lead sponsor: 
has dmc: Yes
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,
      DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for
      DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE
      after pancreaticoduodenectomy.
The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the
      pancreas, periampullary tumors and intractable inflammatory pathology.

      The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery.
      The most common complication is delayed gastric emptying (DGE), defined as the intolerance to
      solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur
      after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and
      prolonged hospital stay.

      The aim of the study is to compare the effect of Roux-en Y reconstruction (study group,
      DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for
      DPC.

      The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after
      pancreaticoduodenectomy.

      A pilot randomized clinical trial has been designed to compare two surgical techniques for
      reconstruction of digestive tract after DPC in patients treated in our center. The patients
      are randomized after tumor resection and before the reconstruction througt computer-generated
      random numbers using a sealed envelope technique. The primary endpoint is the incidence of
      DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic
      fistula, the hospital stay, and postoperative endocrine and exocrine function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Delayed gastric emptying incidence after pancreaticoduodenectomy
time frame: within the first 60 daysafter surgery
description: DGE, defined as oral diet intolerance from the 7th postoperative day, and the persistence of nasogastric tube on the 4th postoperative day or later, according to the ISGPS criteria
measure: Morbidity and complications after pancreaticoduodenectomy
time frame: within the first 60 daysafter surgery
description: Postoperative morbidity was defined as any complication that appeared during hospital admission. Postoperative complications and postoperative mortality were defined according to the Clavien-Dindo classification.
arm group label: DPC DN
arm group type: Experimental
description: Roux-en Y reconstruction after pancreaticoduodenectomy
arm group label: DPC UN
arm group type: Active Comparator
description: Child reconstruction after pancreaticoduodenectomy
intervention type: Procedure
intervention name: Pancreaticoduodenectomy
description: Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconstruction techniques.
arm group label: DPC DN
arm group label: DPC UN
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: JULI BUSQUETS
role: Principal Investigator
affiliation: Hospital Universitari de Bellvitge
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: JULI BUSQUETS BARENYS
investigator title: Medicine Doctor
mesh term: Neoplasms