<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/NCT03813368</url>
  </required_header>
  <id_info>
    <org_study_id>258426</org_study_id>
    <nct_id>NCT03813368</nct_id>
  </id_info>
  <brief_title>Whipples Resection in Octogenarians</brief_title>
  <official_title>Short and Long Term Outcomes of Whipples Resection in the Over 80s</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</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>
      Whipples resection is an operation that has a burden of high morbidity and mortality. It is&#xD;
      performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common&#xD;
      indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when&#xD;
      curative surgery has been performed. Short and long term outcomes however, have improved&#xD;
      recently and the indications for curative resection have been increasingly extended,&#xD;
      including operating on those that previously may have been considered too old to benefit from&#xD;
      curative resection.&#xD;
&#xD;
      Little is known about the benefit of performing this procedure in the oldest patients.&#xD;
      Performing Whipples resection in patients over the age of 70 has been reported and has been&#xD;
      shown to result in satisfactory perioperative results with comparable long term outcomes to&#xD;
      those under 70. However the benefit of performing the same procedure in the over 80 age group&#xD;
      is less well reported and consistently presents a challenging decision for the clinician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whipples resection is an operation that has a burden of high morbidity and mortality. It is&#xD;
      performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common&#xD;
      indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when&#xD;
      curative surgery has been performed. Short and long term outcomes however, have improved&#xD;
      recently and the indications for curative resection have been increasingly extended,&#xD;
      including operating on those that previously may have been considered too old to benefit from&#xD;
      curative resection.&#xD;
&#xD;
      Little is known about the benefit of performing this procedure in the oldest patients.&#xD;
      Performing Whipples resection in patients over the age of 70 has been reported and has been&#xD;
      shown to result in satisfactory perioperative results with comparable long term outcomes to&#xD;
      those under 70. However the benefit of performing the same procedure in the over 80 age group&#xD;
      is less well reported and consistently presents a challenging decision for the clinician.&#xD;
&#xD;
      This study therefore aims to assess the short and long term outcomes of patients undergoing&#xD;
      Whipples PD in the over 80 age group in Lothian. This will be combined with data from all the&#xD;
      other units in Scotland that perform Whipples resection (Dundee, Glasgow and Aberdeen)&#xD;
&#xD;
      The primary outcome will be overall and disease free survival.&#xD;
&#xD;
      Participants will be identified by using procedure specific codes to identify those patients&#xD;
      who underwent Whipples pancreaticoduodenectomy from the ORSOS prospectively collated theatre&#xD;
      record database. The other centres in Scotland will identify their subjects via their own&#xD;
      methodology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>survival</measure>
    <time_frame>10 years</time_frame>
    <description>Time from surgery to death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>10 years</time_frame>
    <description>Time from surgery to recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>90 days</time_frame>
    <description>Clavien Dindo grade of post-oepraitve complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Destination</measure>
    <time_frame>5 years</time_frame>
    <description>Where the patient has been discharged from hospital to - home, nursing home, care home, home with support</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pancreatic Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whipples pancreatico-duodenectomy</intervention_name>
    <description>Classic whipples and pylorus preserving</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had whipples pancreatico-duodenectomy in Scotland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing Whipples PD from 1998-2018 in Scotland&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incorrectly coded as Whipples resection&#xD;
&#xD;
          -  Underwent non curative bypass procedures.&#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>Michael Hughes</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lothian</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael J Hughes</last_name>
    <phone>07734429759</phone>
    <email>michaelh@doctors.net.uk</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03813368
org study id: 258426
nct id: NCT03813368
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whipples resection is an operation that has a burden of high morbidity and mortality. It is
      performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common
      indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when
      curative surgery has been performed. Short and long term outcomes however, have improved
      recently and the indications for curative resection have been increasingly extended,
      including operating on those that previously may have been considered too old to benefit from
      curative resection.

      Little is known about the benefit of performing this procedure in the oldest patients.
      Performing Whipples resection in patients over the age of 70 has been reported and has been
      shown to result in satisfactory perioperative results with comparable long term outcomes to
      those under 70. However the benefit of performing the same procedure in the over 80 age group
      is less well reported and consistently presents a challenging decision for the clinician.
Whipples resection is an operation that has a burden of high morbidity and mortality. It is
      performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common
      indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when
      curative surgery has been performed. Short and long term outcomes however, have improved
      recently and the indications for curative resection have been increasingly extended,
      including operating on those that previously may have been considered too old to benefit from
      curative resection.

      Little is known about the benefit of performing this procedure in the oldest patients.
      Performing Whipples resection in patients over the age of 70 has been reported and has been
      shown to result in satisfactory perioperative results with comparable long term outcomes to
      those under 70. However the benefit of performing the same procedure in the over 80 age group
      is less well reported and consistently presents a challenging decision for the clinician.

      This study therefore aims to assess the short and long term outcomes of patients undergoing
      Whipples PD in the over 80 age group in Lothian. This will be combined with data from all the
      other units in Scotland that perform Whipples resection (Dundee, Glasgow and Aberdeen)

      The primary outcome will be overall and disease free survival.

      Participants will be identified by using procedure specific codes to identify those patients
      who underwent Whipples pancreaticoduodenectomy from the ORSOS prospectively collated theatre
      record database. The other centres in Scotland will identify their subjects via their own
      methodology.
observational model: Cohort
time perspective: Retrospective
measure: survival
time frame: 10 years
description: Time from surgery to death
measure: Disease free survival
time frame: 10 years
description: Time from surgery to recurrence
measure: Morbidity
time frame: 90 days
description: Clavien Dindo grade of post-oepraitve complication
measure: Discharge Destination
time frame: 5 years
description: Where the patient has been discharged from hospital to - home, nursing home, care home, home with support
intervention type: Procedure
intervention name: Whipples pancreatico-duodenectomy
description: Classic whipples and pylorus preserving
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Hughes
role: Principal Investigator
affiliation: NHS Lothian
last name: Michael J Hughes
phone: 07734429759
email: michaelh@doctors.net.uk
responsible party type: Sponsor
sharing ipd: Undecided