<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/NCT03000946</url>
  </required_header>
  <id_info>
    <org_study_id>P150915</org_study_id>
    <secondary_id>2016-001673-32</secondary_id>
    <nct_id>NCT03000946</nct_id>
  </id_info>
  <brief_title>Prevention of Postoperative Pancreatic Fistula by Somatostatin</brief_title>
  <acronym>PREFIPS</acronym>
  <official_title>Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The purpose of this study is to determine whether somatostatin is more effective that&#xD;
      octreotide in the prevention of post-pancreatectomy pancreatic fistula&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevention of pancreatic fistula remains a major challenge for surgeons, and various&#xD;
      technical and pharmacological intervention have been investigated, with conflicting results.&#xD;
&#xD;
      Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic&#xD;
      fistula of octreotide, remains controversial, even if recommended for routine use in patients&#xD;
      undergoing pancreatic resection.&#xD;
&#xD;
      In view of recent result, the investigators can hypothesize that higher affinity for&#xD;
      somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better&#xD;
      pancreatic fistula prevention.&#xD;
&#xD;
      Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide&#xD;
      hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will&#xD;
      be associated with a improved pancreatic fistula prevention compared to octreotide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">February 9, 2021</completion_date>
  <primary_completion_date type="Actual">February 9, 2021</primary_completion_date>
  <phase>Phase 3</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>≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>≥grade 3 pancreatic complication rates (fistula, leak, and abscess)</measure>
    <time_frame>60 days</time_frame>
    <description>as defined by the MSKCC surgical secondary events system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall pancreatic fistula rate (grade A,B and C)</measure>
    <time_frame>90 days</time_frame>
    <description>previous ISGPF classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall pancreatic fistula rate (grade B and C)</measure>
    <time_frame>90 days</time_frame>
    <description>last ISGPF classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall complication rate (grade 1 to 5)</measure>
    <time_frame>90 days</time_frame>
    <description>according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe complication rate (grade 3 to 5)</measure>
    <time_frame>90 days</time_frame>
    <description>according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (grade 5)</measure>
    <time_frame>90 days</time_frame>
    <description>according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall duration of drainage</measure>
    <time_frame>90 days</time_frame>
    <description>required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall length of stay</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-admission rate</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fistula according to possible new definition of the ISGPF group</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative quality of life after pancreatic surgery</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>only in patients undergoing pancreaticoduodenectomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">655</enrollment>
  <condition>Pancreatic Surgery</condition>
  <arm_group>
    <arm_group_label>Somatostatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Octreotide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatostatin</intervention_name>
    <description>Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days</description>
    <arm_group_label>Somatostatin</arm_group_label>
    <other_name>Somatostatine Eumedica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide</intervention_name>
    <description>Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days</description>
    <arm_group_label>Octreotide</arm_group_label>
    <other_name>Siroctid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged 18 years or greater&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without&#xD;
             splenectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with radiation therapy&#xD;
&#xD;
          -  Patient with neoadjuvant chemotherapy within 4 weeks before surgery&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Patients who have any current or prior medical condition that may interfere with the&#xD;
             conduct of the study or the evaluation of its results in the opinion of the&#xD;
             Investigator&#xD;
&#xD;
          -  Patients who have participated in any clinical investigation with an investigational&#xD;
             drug within 1 month prior to inclusion&#xD;
&#xD;
          -  Known hypersensitivity to somatostatin or somatostatin analogues or any component of&#xD;
             the somatostatin or octreotide long-acting release (LAR) or s.c. formulations&#xD;
&#xD;
          -  Patient previously treated with somatostatin or somatostatin analogues or any&#xD;
             component of the somatostatin or octreotide LAR or s.c. formulations&#xD;
&#xD;
          -  Patients treated by ciclosporin&#xD;
&#xD;
          -  Patient without health insurance or social security&#xD;
&#xD;
          -  Patients with a history of non-compliance to medical regimens or who are considered&#xD;
             potentially unreliable or will be unable to complete the entire study&#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_official>
    <last_name>Sébastien GAUJOUX, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Pitié Salpêtrière Hospital, AP-HP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bertrand DOUSSET, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cochin Hospital, AP-HP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>La Pitié Salpêtrière Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatectomy</keyword>
  <keyword>Somatostatin analogue</keyword>
  <keyword>Octreotide</keyword>
  <keyword>Pancreatic fistula</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>Octreotide</mesh_term>
    <mesh_term>Somatostatin</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/NCT03000946
org study id: P150915
secondary id: 2016-001673-32
nct id: NCT03000946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether somatostatin is more effective that
      octreotide in the prevention of post-pancreatectomy pancreatic fistula
Prevention of pancreatic fistula remains a major challenge for surgeons, and various
      technical and pharmacological intervention have been investigated, with conflicting results.

      Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic
      fistula of octreotide, remains controversial, even if recommended for routine use in patients
      undergoing pancreatic resection.

      In view of recent result, the investigators can hypothesize that higher affinity for
      somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better
      pancreatic fistula prevention.

      Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide
      hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will
      be associated with a improved pancreatic fistula prevention compared to octreotide.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
time frame: 90 days
measure: ≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
time frame: 60 days
description: as defined by the MSKCC surgical secondary events system
measure: Overall pancreatic fistula rate (grade A,B and C)
time frame: 90 days
description: previous ISGPF classification
measure: Overall pancreatic fistula rate (grade B and C)
time frame: 90 days
description: last ISGPF classification
measure: Overall complication rate (grade 1 to 5)
time frame: 90 days
description: according to Clavien-Dindo classification
measure: Severe complication rate (grade 3 to 5)
time frame: 90 days
description: according to Clavien-Dindo classification
measure: Mortality (grade 5)
time frame: 90 days
description: according to Clavien-Dindo classification
measure: Overall duration of drainage
time frame: 90 days
description: required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
measure: Overall length of stay
time frame: 90 days
measure: Re-admission rate
time frame: 90 days
measure: Cost effectiveness
time frame: 90 days
measure: Fistula according to possible new definition of the ISGPF group
time frame: 90 days
measure: Postoperative quality of life after pancreatic surgery
time frame: 7 days after surgery
description: only in patients undergoing pancreaticoduodenectomy
arm group label: Somatostatin
arm group type: Experimental
description: Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days
arm group label: Octreotide
arm group type: Active Comparator
description: Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.
intervention type: Drug
intervention name: Somatostatin
description: Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days
arm group label: Somatostatin
other name: Somatostatine Eumedica
intervention type: Drug
intervention name: Octreotide
description: Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
arm group label: Octreotide
other name: Siroctid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien GAUJOUX, MD, PhD
role: Principal Investigator
affiliation: La Pitié Salpêtrière Hospital, AP-HP
last name: Bertrand DOUSSET, MD, PhD
role: Study Chair
affiliation: Cochin Hospital, AP-HP
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Pancreatic Fistula
mesh term: Fistula
mesh term: Octreotide
mesh term: Somatostatin
sharing ipd: No