<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/NCT04402346</url>
  </required_header>
  <id_info>
    <org_study_id>HMar_RF_transection_pancreas</org_study_id>
    <nct_id>NCT04402346</nct_id>
  </id_info>
  <brief_title>Radiofrequency-assisted Transection of the Pancreas vs Stapler</brief_title>
  <acronym>TRANSPAIRE</acronym>
  <official_title>Radiofrequency-assisted Transection of the Pancreas vs Stapler. A Phase III Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patricia Sanchez Velazquez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Mar</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Main objective: The main end-point of this study is to compare in a randomized clinical trial&#xD;
      that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative&#xD;
      pancreatic fistula (POPF) compared to the classical method of transection (stapler). As&#xD;
      secondary end-points, other clinical and demographic variables of the patients will be&#xD;
      evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of&#xD;
      procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct&#xD;
      size, duration of intervention, type of tumor and quality of lymphatic resection).&#xD;
      Methodology: Phase III prospective multicenter study in patients undergoing distal&#xD;
      pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy&#xD;
      for any cause in a multicenter setting will be included. A simple randomization of the&#xD;
      participants to the RFA group or to the control group (stapler) will be carried out. The&#xD;
      incidence of pancreatic fistula will be assessed as main variable; predictive multivariable&#xD;
      models with multiple regression for quantitative variables, logistic regression for&#xD;
      categorical variables and Cox regression for survival analyzes. In addition to histological&#xD;
      study, molecular analysis of resection specimen and clinical and radiological follow-up with&#xD;
      volumetry of necrosis in the area of post-pancreatectomy transection will be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pancreas fistula</measure>
    <time_frame>90 days follow-up</time_frame>
    <description>Defined by the updated 2016 ISGPF definition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital Mortality</measure>
    <time_frame>In-Hospital (30 days)</time_frame>
    <description>30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>90 days follow-up</time_frame>
    <description>In terms of Clavien-Dindo and CCI classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Pancreas; Fistula</condition>
  <arm_group>
    <arm_group_label>Radiofrequency-assisted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stapler</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency-assisted pancreas transection</intervention_name>
    <description>Transection of the pancreas in distal pancreatectomy by applying a radio frequency device</description>
    <arm_group_label>Radiofrequency-assisted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stapler assisted pancreas transection</intervention_name>
    <description>Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard</description>
    <arm_group_label>Stapler</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Solid or cystic, benign or malign pancreas neoplasms.&#xD;
&#xD;
          -  Patients undergoing a distal pancreatectomy, i.e pancreas transection beyond &gt; 2 cm&#xD;
             from the SMV (assessed by computer tomography or RM) with or without splenectomy&#xD;
&#xD;
          -  Both open and laparoscopic approaches are valid.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who required a pancreatectomy with transection at the level of the neck.&#xD;
&#xD;
          -  Non-intervention group: only stapler transection will be accepted, other pancreatic&#xD;
             transection methods will be excluded.&#xD;
&#xD;
          -  Patients ASA≥IV&#xD;
&#xD;
          -  Absence of informed consent&#xD;
&#xD;
          -  Underage (&lt;18 years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patricia Sánchez-Velázquez, MD PhD FEBS</last_name>
    <phone>+34 932483207</phone>
    <email>Psanchezvelazquez@psmar.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernando Burdío, MD PhD</last_name>
    <email>fburdio@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Parc de Salut Mar de Barcelona- Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08019</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Sánchez-Velázquez, MD PhD FEBS</last_name>
      <email>Psanchezvelazquez@psmar.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Mar</investigator_affiliation>
    <investigator_full_name>Patricia Sanchez Velazquez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pancreas fistula</keyword>
  <keyword>Distal pancreatectomy</keyword>
  <keyword>Radiofrequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancrelipase</mesh_term>
    <mesh_term>Pancreatin</mesh_term>
  </intervention_browse>
  <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/NCT04402346
org study id: HMar_RF_transection_pancreas
nct id: NCT04402346
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Main objective: The main end-point of this study is to compare in a randomized clinical trial
      that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative
      pancreatic fistula (POPF) compared to the classical method of transection (stapler). As
      secondary end-points, other clinical and demographic variables of the patients will be
      evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of
      procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct
      size, duration of intervention, type of tumor and quality of lymphatic resection).
      Methodology: Phase III prospective multicenter study in patients undergoing distal
      pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy
      for any cause in a multicenter setting will be included. A simple randomization of the
      participants to the RFA group or to the control group (stapler) will be carried out. The
      incidence of pancreatic fistula will be assessed as main variable; predictive multivariable
      models with multiple regression for quantitative variables, logistic regression for
      categorical variables and Cox regression for survival analyzes. In addition to histological
      study, molecular analysis of resection specimen and clinical and radiological follow-up with
      volumetry of necrosis in the area of post-pancreatectomy transection will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pancreas fistula
time frame: 90 days follow-up
description: Defined by the updated 2016 ISGPF definition
measure: In-hospital Mortality
time frame: In-Hospital (30 days)
description: 30 days
measure: Morbidity
time frame: 90 days follow-up
description: In terms of Clavien-Dindo and CCI classification
arm group label: Radiofrequency-assisted
arm group type: Experimental
arm group label: Stapler
arm group type: Active Comparator
intervention type: Procedure
intervention name: Radiofrequency-assisted pancreas transection
description: Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
arm group label: Radiofrequency-assisted
intervention type: Procedure
intervention name: Stapler assisted pancreas transection
description: Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard
arm group label: Stapler
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Sánchez-Velázquez, MD PhD FEBS
phone: +34 932483207
email: Psanchezvelazquez@psmar.cat
last name: Fernando Burdío, MD PhD
email: fburdio@hotmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital del Mar
investigator full name: Patricia Sanchez Velazquez
investigator title: Principal Investigator
mesh term: Pancreatic Fistula
mesh term: Fistula
mesh term: Pancrelipase
mesh term: Pancreatin
sharing ipd: No