<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/NCT04483726</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL19_0340</org_study_id>
    <nct_id>NCT04483726</nct_id>
  </id_info>
  <brief_title>Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)</brief_title>
  <acronym>DIPLOMA</acronym>
  <official_title>Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AIDS Malignancy Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal&#xD;
      adenocarcinoma (PDAC) in the pancreatic body or tail.&#xD;
&#xD;
      Study design: A pan-European, randomized controlled, multicenter, patient-blinded&#xD;
      non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.&#xD;
      Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs&#xD;
      ODP). A blinded adjudication committee will assess all endpoints.&#xD;
&#xD;
      Study population: Two groups of 129 patients (258 in total) with an indication for elective&#xD;
      distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.&#xD;
&#xD;
      Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or&#xD;
      robot-assisted)&#xD;
&#xD;
      Control: Open distal pancreatectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Several systematic reviews have suggested superior short term outcomes after&#xD;
      minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy&#xD;
      (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European&#xD;
      survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic&#xD;
      safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic&#xD;
      cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs&#xD;
      ODP for pancreatic cancer is needed.&#xD;
&#xD;
      Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal&#xD;
      adenocarcinoma (PDAC) in the pancreatic body or tail.&#xD;
&#xD;
      Study design: A pan-European, randomized controlled, multicenter, patient-blinded&#xD;
      non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.&#xD;
      Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs&#xD;
      ODP). A blinded adjudication committee will assess all endpoints.&#xD;
&#xD;
      Study population: Two groups of 129 patients (258 in total) with an indication for elective&#xD;
      distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.&#xD;
&#xD;
      Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or&#xD;
      robot-assisted)&#xD;
&#xD;
      Control: Open distal pancreatectomy&#xD;
&#xD;
      Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, &gt;1mm)&#xD;
      resection rate. Main secondary outcomes are survival, lymph node retrieval, intraoperative&#xD;
      outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as&#xD;
      complications, time to functional recovery and hospital stay) and quality of life&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 9, 2025</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>microscopically radical resection rate</measure>
    <time_frame>1 day</time_frame>
    <description>R0, &gt;1mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>1 year</time_frame>
    <description>Date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>2 years</time_frame>
    <description>Date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>3 years</time_frame>
    <description>Date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lymph node retrieval</measure>
    <time_frame>1 day</time_frame>
    <description>Tumor positive lymph nodes retrieved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day</time_frame>
    <description>Operative time from first incision to closure of the abdomen, minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>Intraoperative blood loss, mL (suction canister and weight of gauzes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative outcomes</measure>
    <time_frame>1 day</time_frame>
    <description>Total duration of the procedure, minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative outcomes</measure>
    <time_frame>1 day</time_frame>
    <description>Major complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>specimen size</measure>
    <time_frame>1 day</time_frame>
    <description>Tumor size, mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specimen length</measure>
    <time_frame>1 day</time_frame>
    <description>Specimen length, mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>margin</measure>
    <time_frame>1 day</time_frame>
    <description>Distance from tumor to transection, anterior and posterior margin, mm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>MIDP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>minimally invasive distal pancreatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ODP</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>open distal pancreatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimally invasive distal pancreatectomy</intervention_name>
    <description>Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)</description>
    <arm_group_label>MIDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open distal pancreatectomy</intervention_name>
    <description>open distal pancreatectomy</description>
    <arm_group_label>ODP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years;&#xD;
&#xD;
          -  Elective indication for distal pancreatectomy for proven or suspected PDAC;&#xD;
&#xD;
          -  Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC&#xD;
             in the pancreatic body or tail;&#xD;
&#xD;
          -  The tumor can be radically resected via both minimally invasive or open surgery&#xD;
             according to the local treating team;&#xD;
&#xD;
          -  The patient is fit to undergo both open and minimally invasive distal pancreatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  score of American society of anaesthesiologists (ASA) &gt;3;&#xD;
&#xD;
          -  A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);&#xD;
&#xD;
          -  Second malignancy necessitating resection during the same procedure;&#xD;
&#xD;
          -  Distant metastases (M1) including involved distant lymph nodes;&#xD;
&#xD;
          -  Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or&#xD;
             portomesenteric vein);&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Participation in another study with interference of study outcomes.&#xD;
&#xD;
          -  Cystic lesion having undergone malignant transformation&#xD;
&#xD;
               -  the celiac trunk should be 5mm clear from tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Beaujon - APHP</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint Eloi - Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Orléans</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Paul Brousse</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreas</keyword>
  <keyword>pancreatic</keyword>
  <keyword>surgery</keyword>
  <keyword>minimally-invasive</keyword>
  <keyword>cancer</keyword>
  <keyword>adenocarcinoma</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>randomized</keyword>
  <keyword>prospective</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_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/NCT04483726
org study id: RECHMPL19_0340
nct id: NCT04483726
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal
      adenocarcinoma (PDAC) in the pancreatic body or tail.

      Study design: A pan-European, randomized controlled, multicenter, patient-blinded
      non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
      Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs
      ODP). A blinded adjudication committee will assess all endpoints.

      Study population: Two groups of 129 patients (258 in total) with an indication for elective
      distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

      Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or
      robot-assisted)

      Control: Open distal pancreatectomy
Rationale: Several systematic reviews have suggested superior short term outcomes after
      minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy
      (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European
      survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic
      safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic
      cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs
      ODP for pancreatic cancer is needed.

      Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal
      adenocarcinoma (PDAC) in the pancreatic body or tail.

      Study design: A pan-European, randomized controlled, multicenter, patient-blinded
      non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
      Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs
      ODP). A blinded adjudication committee will assess all endpoints.

      Study population: Two groups of 129 patients (258 in total) with an indication for elective
      distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

      Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or
      robot-assisted)

      Control: Open distal pancreatectomy

      Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, >1mm)
      resection rate. Main secondary outcomes are survival, lymph node retrieval, intraoperative
      outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as
      complications, time to functional recovery and hospital stay) and quality of life
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: microscopically radical resection rate
time frame: 1 day
description: R0, >1mm
measure: survival
time frame: 1 year
description: Date of death
measure: survival
time frame: 2 years
description: Date of death
measure: survival
time frame: 3 years
description: Date of death
measure: lymph node retrieval
time frame: 1 day
description: Tumor positive lymph nodes retrieved
measure: Operative time
time frame: 1 day
description: Operative time from first incision to closure of the abdomen, minutes
measure: Intraoperative blood loss
time frame: 1 day
description: Intraoperative blood loss, mL (suction canister and weight of gauzes)
measure: intraoperative outcomes
time frame: 1 day
description: Total duration of the procedure, minutes
measure: postoperative outcomes
time frame: 1 day
description: Major complications
measure: specimen size
time frame: 1 day
description: Tumor size, mm
measure: Specimen length
time frame: 1 day
description: Specimen length, mm
measure: margin
time frame: 1 day
description: Distance from tumor to transection, anterior and posterior margin, mm
arm group label: MIDP
arm group type: Experimental
description: minimally invasive distal pancreatectomy
arm group label: ODP
arm group type: Sham Comparator
description: open distal pancreatectomy
intervention type: Procedure
intervention name: minimally invasive distal pancreatectomy
description: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
arm group label: MIDP
intervention type: Procedure
intervention name: open distal pancreatectomy
description: open distal pancreatectomy
arm group label: ODP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: No