<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/NCT02220010</url>
  </required_header>
  <id_info>
    <org_study_id>POPF and stenting-002</org_study_id>
    <nct_id>NCT02220010</nct_id>
  </id_info>
  <brief_title>Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?</brief_title>
  <official_title>Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahlgren´s University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norrlands University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dividing pancreas when performing left-sided resections opens the risk for leakage from the&#xD;
      divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding&#xD;
      abdominal tissues with abscess formation producing systemic inflammation and potential lethal&#xD;
      bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage&#xD;
      reduces healing time. A pancreatic stent could theoretically improve the drainage of&#xD;
      pancreatic juice into the duodenum and by this shorten the healing time still further.&#xD;
&#xD;
      Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not&#xD;
      shown a positive effect on fistula formation.&#xD;
&#xD;
      In an open randomized multicenter clinical trial we want to test the hypothesis that a&#xD;
      reduced fistula healing time, in left sided pancreatic resections, could be reduced by&#xD;
      introducing a pancreatic stent when on post operative day 3 or later a B och C fistula&#xD;
      (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by&#xD;
      randomizing between pancreatic stent with drains versus only drains.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>POPF healing time (days)</measure>
    <time_frame>12 days (median hospital stay)</time_frame>
    <description>Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>POPF grade (A,B,C)</measure>
    <time_frame>12 days (median hospital stay)</time_frame>
    <description>International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al 2005)defines fistula grade A-C. Grade A is leakage of pancreatic juice with a concentration of more than 3 times the upper normal level in plasma but no other clinical implication for the patient. If an inflammatory response is seen, but not sepsis, it is graded as B fistula and if sepsis occurs and/or single- or multi-organ dysfunction is seen it is graded as C.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood chemistry</measure>
    <time_frame>12 days (median hospital stay)</time_frame>
    <description>C-reactive protein, white blood cell count and pancreas amylase in plasma and drains</description>
  </other_outcome>
  <other_outcome>
    <measure>Morbidity</measure>
    <time_frame>12 days (median in hospital stay)</time_frame>
    <description>Classification according to Clavien-Dindo</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>&lt; 90 days after the operation</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospital stay</measure>
    <time_frame>12 days (median hospital stay)</time_frame>
    <description>Number of days in hospital</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Healing Time of Post Operative Pancreatic Fistulas</condition>
  <arm_group>
    <arm_group_label>Pancreatic stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drain only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pancreatic stent</intervention_name>
    <description>The plastic stent is introduced in the pancreatic duct by a duodenoscope</description>
    <arm_group_label>Pancreatic stent</arm_group_label>
    <other_name>Pancreatic duct stent (made of plastic material)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Left sided or distal pancreatic resection&#xD;
&#xD;
          -  Grade B or C fistula on postoperative day 3 or later&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not want to participate in study&#xD;
&#xD;
          -  Can not read patient information in swedish&#xD;
&#xD;
          -  The papilla can not be endoscopically reached&#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>Dep of Surgical Gastroenterology, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Blomberg, MD, PhD</last_name>
      <phone>+46(0)703983060</phone>
      <email>john.blomberg@karolinska.se</email>
    </contact>
    <contact_backup>
      <last_name>Christoph Ansorge, MD, PhD</last_name>
      <email>christoph.ansorge@karolinska.se</email>
    </contact_backup>
    <investigator>
      <last_name>John Blomberg, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Ansorge, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>John Blomberg</investigator_full_name>
    <investigator_title>M.D., PhD</investigator_title>
  </responsible_party>
  <keyword>Post operative pancreatic fistulas</keyword>
  <keyword>Pancreatic stenting</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>
  <!-- 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/NCT02220010
org study id: POPF and stenting-002
nct id: NCT02220010
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Dividing pancreas when performing left-sided resections opens the risk for leakage from the
      divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding
      abdominal tissues with abscess formation producing systemic inflammation and potential lethal
      bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage
      reduces healing time. A pancreatic stent could theoretically improve the drainage of
      pancreatic juice into the duodenum and by this shorten the healing time still further.

      Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not
      shown a positive effect on fistula formation.

      In an open randomized multicenter clinical trial we want to test the hypothesis that a
      reduced fistula healing time, in left sided pancreatic resections, could be reduced by
      introducing a pancreatic stent when on post operative day 3 or later a B och C fistula
      (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by
      randomizing between pancreatic stent with drains versus only drains.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: POPF healing time (days)
time frame: 12 days (median hospital stay)
description: Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed.
measure: POPF grade (A,B,C)
time frame: 12 days (median hospital stay)
description: International Study Group on Pancreatic Fistula (ISGPF) (Bassi et al 2005)defines fistula grade A-C. Grade A is leakage of pancreatic juice with a concentration of more than 3 times the upper normal level in plasma but no other clinical implication for the patient. If an inflammatory response is seen, but not sepsis, it is graded as B fistula and if sepsis occurs and/or single- or multi-organ dysfunction is seen it is graded as C.
measure: Blood chemistry
time frame: 12 days (median hospital stay)
description: C-reactive protein, white blood cell count and pancreas amylase in plasma and drains
measure: Morbidity
time frame: 12 days (median in hospital stay)
description: Classification according to Clavien-Dindo
measure: Mortality
time frame: < 90 days after the operation
measure: Hospital stay
time frame: 12 days (median hospital stay)
description: Number of days in hospital
arm group label: Pancreatic stent
arm group type: Experimental
description: If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct.
arm group label: Drain only
arm group type: No Intervention
description: If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment
intervention type: Device
intervention name: Pancreatic stent
description: The plastic stent is introduced in the pancreatic duct by a duodenoscope
arm group label: Pancreatic stent
other name: Pancreatic duct stent (made of plastic material)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: John Blomberg
investigator title: M.D., PhD
mesh term: Pancreatic Fistula
mesh term: Fistula