<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/NCT03822676</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-1833</org_study_id>
    <nct_id>NCT03822676</nct_id>
  </id_info>
  <brief_title>Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula</brief_title>
  <official_title>Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after&#xD;
      pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was&#xD;
      effective in the treatment of POPF. However, the results of prospective RCTs for the&#xD;
      prophylactic effect of pancreatic stent insertion against POPF were controversial. This&#xD;
      single center prospective randomized trial was designed to compare the outcome after&#xD;
      segmental pancreatectomy with prophylactic drainage stent versus no stent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pancreatic fistula</measure>
    <time_frame>from postoperative day 3 to 30</time_frame>
    <description>Grade B and C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of pancreatic fistula</measure>
    <time_frame>from postoperative day 3 to 30</time_frame>
    <description>Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>from postoperative day 1 to discharge</time_frame>
    <description>Length of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Pancreatic Fistula</condition>
  <arm_group>
    <arm_group_label>Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prophylactic pancreatic stent before segmental pancreatic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No stent</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No prophylactic stent before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prophylactic pancreatic stent</intervention_name>
    <description>Prophylactic pancreatic stent before segmental pancreatic surgery</description>
    <arm_group_label>Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients scheduled for elective segmental pancreatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects for whom ERCP procedures are contraindicated&#xD;
&#xD;
          -  If female, pregnant based on a positive hCG serum or an in vitro diagnostic test&#xD;
             result or breast-feeding&#xD;
&#xD;
          -  Age less than 18 year&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Previous pancreatic surgery&#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>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aiming Yang, M.D.</last_name>
      <phone>+86-10-69151593</phone>
      <email>yangaiming@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yunlu Feng, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03822676
org study id: ZS-1833
nct id: NCT03822676
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after
      pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was
      effective in the treatment of POPF. However, the results of prospective RCTs for the
      prophylactic effect of pancreatic stent insertion against POPF were controversial. This
      single center prospective randomized trial was designed to compare the outcome after
      segmental pancreatectomy with prophylactic drainage stent versus no stent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Postoperative pancreatic fistula
time frame: from postoperative day 3 to 30
description: Grade B and C
measure: Severity of pancreatic fistula
time frame: from postoperative day 3 to 30
description: Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
measure: Length of stay
time frame: from postoperative day 1 to discharge
description: Length of hospital stay
arm group label: Stent
arm group type: Experimental
description: Prophylactic pancreatic stent before segmental pancreatic surgery
arm group label: No stent
arm group type: No Intervention
description: No prophylactic stent before surgery
intervention type: Device
intervention name: Prophylactic pancreatic stent
description: Prophylactic pancreatic stent before segmental pancreatic surgery
arm group label: Stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Fistula
mesh term: Fistula