<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/NCT04462354</url>
  </required_header>
  <id_info>
    <org_study_id>PANGASBLUM</org_study_id>
    <nct_id>NCT04462354</nct_id>
  </id_info>
  <brief_title>Pancreatic Anastomosis After Duodenopancreatectomy</brief_title>
  <acronym>PANGASBLUM</acronym>
  <official_title>Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</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>
      A national, multicenter, randomized, prospective, parallel group clinical study to evaluate&#xD;
      two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart&#xD;
      anastomosis).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Postoperative pancreatic fistula is currently the most frequent complications&#xD;
      after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently&#xD;
      used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis&#xD;
      versus Blumgart anastomosis)&#xD;
&#xD;
      Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a&#xD;
      Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy&#xD;
      decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric&#xD;
      anastomosis.&#xD;
&#xD;
      Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and&#xD;
      periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with&#xD;
      Blumgart anastomosis or pancreatogastric anastomosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 4, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pancreatic fistula rate (PPF)</measure>
    <time_frame>3 months</time_frame>
    <description>The post-operative pancreatic fistula (PPF) rate will be measured using the definition of the International Study Group of Pancreatic Fistula (ISGPF) : any measurable amount of fluid from a drain placed during the operation or percutaneously, with an amylase concentration greater than three times the plasma value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>3 months</time_frame>
    <description>According to the definition of the International Study Group on Pancreatic Surgery. which grades the severity of bleeding according to the clinical situation, diagnosis and need for treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric Emptying Delay (GED)</measure>
    <time_frame>3 months</time_frame>
    <description>According to the definition of the International Study Group on Pancreatic Surgery, which establishes the existence of GED when a nasogastric tube is needed for more than 3 days or is placed from the third day of the postoperative period, as well as intolerance to an oral diet at the end of the first postoperative week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biliary Fistula</measure>
    <time_frame>3 months</time_frame>
    <description>According to the definition of the International Study Group of Liver Surgery, which defines it as any measurable amount of fluid from a drain placed during the operation or percutaneously, with a concentration of bilirubin greater than three times the plasma value as of the third post-operative day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other complications.</measure>
    <time_frame>3 months</time_frame>
    <description>All complications that may occur during the first 90 days of the postoperative period (including the mortality rate) should be collected and classified according to the Clavien-Dindo classification and the Comprehensive Complication Index (CCI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Pancreatic Anastomotic Leak</condition>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pancreatogastric anastomosis.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Blumgart Anastomosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blumgart Anastomosis</intervention_name>
    <description>Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis</description>
    <arm_group_label>Blumgart Anastomosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreatogastric anastomosis.</intervention_name>
    <description>Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.</description>
    <arm_group_label>Pancreatogastric anastomosis.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old.&#xD;
&#xD;
          -  Diagnosis of pancreatic and periampullary tumor pathology that requires&#xD;
             pancreatoduodenectomy&#xD;
&#xD;
          -  Signature of informed consent by the patient or his legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom liver metastases or peritoneal carcinomatosis are detected during&#xD;
             surgery.&#xD;
&#xD;
          -  Patients in whom tumor resection is ultimately not achieved due to intraoperative&#xD;
             evidence that the tumor is locally advanced, unresectable.&#xD;
&#xD;
          -  Patients with macroscopic residual tumor (R2).&#xD;
&#xD;
          -  High risk patients with severe pathology (ASA IV) according to the American&#xD;
             Association of Anesthetists.&#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>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</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 Neoplasms</mesh_term>
    <mesh_term>Anastomotic Leak</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/NCT04462354
org study id: PANGASBLUM
nct id: NCT04462354
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A national, multicenter, randomized, prospective, parallel group clinical study to evaluate
      two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart
      anastomosis).
Background: Postoperative pancreatic fistula is currently the most frequent complications
      after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently
      used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis
      versus Blumgart anastomosis)

      Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a
      Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy
      decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric
      anastomosis.

      Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and
      periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with
      Blumgart anastomosis or pancreatogastric anastomosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Postoperative pancreatic fistula rate (PPF)
time frame: 3 months
description: The post-operative pancreatic fistula (PPF) rate will be measured using the definition of the International Study Group of Pancreatic Fistula (ISGPF) : any measurable amount of fluid from a drain placed during the operation or percutaneously, with an amylase concentration greater than three times the plasma value.
measure: Bleeding
time frame: 3 months
description: According to the definition of the International Study Group on Pancreatic Surgery. which grades the severity of bleeding according to the clinical situation, diagnosis and need for treatment.
measure: Gastric Emptying Delay (GED)
time frame: 3 months
description: According to the definition of the International Study Group on Pancreatic Surgery, which establishes the existence of GED when a nasogastric tube is needed for more than 3 days or is placed from the third day of the postoperative period, as well as intolerance to an oral diet at the end of the first postoperative week.
measure: Biliary Fistula
time frame: 3 months
description: According to the definition of the International Study Group of Liver Surgery, which defines it as any measurable amount of fluid from a drain placed during the operation or percutaneously, with a concentration of bilirubin greater than three times the plasma value as of the third post-operative day.
measure: Other complications.
time frame: 3 months
description: All complications that may occur during the first 90 days of the postoperative period (including the mortality rate) should be collected and classified according to the Clavien-Dindo classification and the Comprehensive Complication Index (CCI)
arm group label: Pancreatogastric anastomosis.
arm group type: Active Comparator
arm group label: Blumgart Anastomosis
arm group type: Experimental
intervention type: Procedure
intervention name: Blumgart Anastomosis
description: Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
arm group label: Blumgart Anastomosis
intervention type: Procedure
intervention name: Pancreatogastric anastomosis.
description: Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
arm group label: Pancreatogastric anastomosis.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Anastomotic Leak