<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/NCT03820583</url>
  </required_header>
  <id_info>
    <org_study_id>s11</org_study_id>
    <nct_id>NCT03820583</nct_id>
  </id_info>
  <brief_title>Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center</brief_title>
  <official_title>Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Services Hospital, Lahore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Services Hospital, Lahore</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple&#xD;
      procedure were studied by compiling demographic details of the patients, common presenting&#xD;
      symptoms, various indications for Whipple's procedure, the cofactors which affect the&#xD;
      procedures outcome and morbidity and mortality of the patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was performed by collecting data through predesigned questionnaire about patients&#xD;
      undergoing Whipple's procedure from operation theatres and medical record section. Those&#xD;
      patients, whose tumor was unresectable and undergone palliative surgical procedures were&#xD;
      excluded from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients undergoing Whipple procedure due to pancreatic tumor were included in the study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients developing pancreatic fistula</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients developing hemorrhage</measure>
    <time_frame>2 weeks</time_frame>
    <description>Percentage of patients developing hemorrhage after Whipple procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients developing wound infection</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percentage of patients developing wound infection after Whipple procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>6 weeks</time_frame>
    <description>Mortality of patients undergoing Whipple surgery</description>
  </primary_outcome>
  <enrollment type="Actual">57</enrollment>
  <condition>Whipple Procedure</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whipple Procedure</intervention_name>
    <description>Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients of both sexes with age ranging from 20 years to 70 years&#xD;
&#xD;
          -  patients with pancreatic tumors&#xD;
&#xD;
          -  patients with adequate cardiorespiratory reserves to be fit for prolong general&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unresectable tumors&#xD;
&#xD;
          -  unfit for surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmmood Ayyaz, mbbs, fcps</last_name>
    <role>Study Director</role>
    <affiliation>Services Hospital, Lahore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Services hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Services Hospital, Lahore</investigator_affiliation>
    <investigator_full_name>Dr. SamiUllah</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Whipple procedure, pancreatic carcinoma, biliary stenting,</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03820583
org study id: s11
nct id: NCT03820583
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple
      procedure were studied by compiling demographic details of the patients, common presenting
      symptoms, various indications for Whipple's procedure, the cofactors which affect the
      procedures outcome and morbidity and mortality of the patients.
This study was performed by collecting data through predesigned questionnaire about patients
      undergoing Whipple's procedure from operation theatres and medical record section. Those
      patients, whose tumor was unresectable and undergone palliative surgical procedures were
      excluded from the study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients developing pancreatic fistula
time frame: 4 weeks
description: Percentage of patients developing pancreatic fistula (pancreatic juice collected in drain rich in amylase) after Whipple procedure Enteric leak postoperative complications like pancreatic fistula, anastomotic leakage, hemorrhage, wound infection,mortality
measure: Percentage of patients developing hemorrhage
time frame: 2 weeks
description: Percentage of patients developing hemorrhage after Whipple procedure
measure: Percentage of patients developing wound infection
time frame: 4 weeks
description: Percentage of patients developing wound infection after Whipple procedure
measure: Mortality rate
time frame: 6 weeks
description: Mortality of patients undergoing Whipple surgery
intervention type: Procedure
intervention name: Whipple Procedure
description: Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mahmmood Ayyaz, mbbs, fcps
role: Study Director
affiliation: Services Hospital, Lahore
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Services Hospital, Lahore
investigator full name: Dr. SamiUllah
investigator title: Principle investigator
sharing ipd: Undecided