<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/NCT03770117</url>
  </required_header>
  <id_info>
    <org_study_id>B00101</org_study_id>
    <nct_id>NCT03770117</nct_id>
  </id_info>
  <brief_title>Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease</brief_title>
  <acronym>SIPUP</acronym>
  <official_title>A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</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>
      The aim of this study is to assess whether prehabilitation supervised by an appropriate&#xD;
      multimodality team improves indices of sarcopenia in patients scheduled to undergo&#xD;
      pancreatoduodenectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cachexia is a hallmark feature of pancreatic cancer. Patients with features of cachexia have&#xD;
      worse clinical outcomes. This includes a reduction in quality of life, reduced tolerance of&#xD;
      therapy and a poorer prognosis . Specifically related to patients undergoing pancreatic&#xD;
      surgery clinical evidence of cachexia is associated with higher perioperative complication&#xD;
      rates. Sarcopenia, defined as a decreased muscle mass independent of fat mass, is a feature&#xD;
      of the cachexia associated with pancreatic cancer. Patients with sarcopenia have progressive&#xD;
      and generalised reduced muscle mass and function In patients undergoing surgery for&#xD;
      pancreatic cancer sarcopenia has been associated with increased rates of complication and&#xD;
      worse survival . Treatment of sarcopenia is difficult but includes nutritional support and&#xD;
      pancreatic enzyme replacement therapy (PERT) aimed at reducing malabsorption. Whether&#xD;
      measures aimed at combating sarcopenia can improve clinical outcomes following pancreatic&#xD;
      surgery is currently unknown.&#xD;
&#xD;
      Prehabilitation is a multimodal therapeutic regimen aimed at improving the overall physical&#xD;
      condition of patients prior to surgery with the intention of reducing the incidence of&#xD;
      perioperative complications. Emerging evidence suggests that exercise prior to surgery for&#xD;
      high risk patients scheduled to undergo major abdominal surgery improves aerobic capacity and&#xD;
      can reduce the incidence of perioperative complications . The impact of prehabilitation&#xD;
      undertaken prior to pancreatic surgery on perioperative complication rates has not yet been&#xD;
      investigated.&#xD;
&#xD;
      The aim of this study is to assess whether prehabilitation supervised by an appropriate&#xD;
      multimodality team improves indices of sarcopenia in patients scheduled to undergo&#xD;
      pancreatoduodenectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CT Scan Comparison</measure>
    <time_frame>Within last 5 years.</time_frame>
    <description>CT Scans from patients which underwent the Prehabilitation &amp; standard care will be compared.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Prehabilitation</arm_group_label>
    <description>In this arm of the study, participants will undergo prehabilitation prior to surgery. This is intended to increase the participants overall health prior to surgery to try and increase their general well-being during and after surgery.&#xD;
Prehabilitation is multimodal therapy comprising:&#xD;
Assessment for malnutrition and nutritional support dependent on the outcome&#xD;
Optimisation of management of pancreatic exocrine insufficiency&#xD;
Assessment of muscle mass and strength&#xD;
Individually tailored, goal directed exercise regimen under the care of physiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Procedure</arm_group_label>
    <description>In this arm, participants will not receive any Rehabilitation prior to the surgery. This is the current standard care and will act as the control data for this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prehabilitation</intervention_name>
    <description>Participants who underwent Prehabilitation will have their CT scans analysed.</description>
    <arm_group_label>Prehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Procedure</intervention_name>
    <description>Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.</description>
    <arm_group_label>Standard Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had a pancreatoduodenectomy. Control group will have had standard care&#xD;
        and these CT Scan results will be compared with those who have undergone prehabilitation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Patients treated by pancreatic resection&#xD;
&#xD;
          2. Surgery for malignancy&#xD;
&#xD;
          3. Patients aged over 16&#xD;
&#xD;
          4. CT scans available for assessment&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway&#xD;
&#xD;
          2. Aged under 16&#xD;
&#xD;
          3. Patients not undergoing pancreatic resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Saurabh Jamdar</last_name>
    <role>Study Chair</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>Gtr Manchester</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreas</keyword>
  <keyword>Cancer</keyword>
  <keyword>Sarcopenia</keyword>
  <keyword>Cachexia</keyword>
  <keyword>Prehabilitation</keyword>
  <keyword>Pancreatoduodenectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT03770117
org study id: B00101
nct id: NCT03770117
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess whether prehabilitation supervised by an appropriate
      multimodality team improves indices of sarcopenia in patients scheduled to undergo
      pancreatoduodenectomy.
Cachexia is a hallmark feature of pancreatic cancer. Patients with features of cachexia have
      worse clinical outcomes. This includes a reduction in quality of life, reduced tolerance of
      therapy and a poorer prognosis . Specifically related to patients undergoing pancreatic
      surgery clinical evidence of cachexia is associated with higher perioperative complication
      rates. Sarcopenia, defined as a decreased muscle mass independent of fat mass, is a feature
      of the cachexia associated with pancreatic cancer. Patients with sarcopenia have progressive
      and generalised reduced muscle mass and function In patients undergoing surgery for
      pancreatic cancer sarcopenia has been associated with increased rates of complication and
      worse survival . Treatment of sarcopenia is difficult but includes nutritional support and
      pancreatic enzyme replacement therapy (PERT) aimed at reducing malabsorption. Whether
      measures aimed at combating sarcopenia can improve clinical outcomes following pancreatic
      surgery is currently unknown.

      Prehabilitation is a multimodal therapeutic regimen aimed at improving the overall physical
      condition of patients prior to surgery with the intention of reducing the incidence of
      perioperative complications. Emerging evidence suggests that exercise prior to surgery for
      high risk patients scheduled to undergo major abdominal surgery improves aerobic capacity and
      can reduce the incidence of perioperative complications . The impact of prehabilitation
      undertaken prior to pancreatic surgery on perioperative complication rates has not yet been
      investigated.

      The aim of this study is to assess whether prehabilitation supervised by an appropriate
      multimodality team improves indices of sarcopenia in patients scheduled to undergo
      pancreatoduodenectomy.
observational model: Case-Control
time perspective: Retrospective
measure: CT Scan Comparison
time frame: Within last 5 years.
description: CT Scans from patients which underwent the Prehabilitation & standard care will be compared.
arm group label: Prehabilitation
description: In this arm of the study, participants will undergo prehabilitation prior to surgery. This is intended to increase the participants overall health prior to surgery to try and increase their general well-being during and after surgery.
Prehabilitation is multimodal therapy comprising:
Assessment for malnutrition and nutritional support dependent on the outcome
Optimisation of management of pancreatic exocrine insufficiency
Assessment of muscle mass and strength
Individually tailored, goal directed exercise regimen under the care of physiotherapy
arm group label: Standard Procedure
description: In this arm, participants will not receive any Rehabilitation prior to the surgery. This is the current standard care and will act as the control data for this study.
intervention type: Procedure
intervention name: Prehabilitation
description: Participants who underwent Prehabilitation will have their CT scans analysed.
arm group label: Prehabilitation
intervention type: Procedure
intervention name: Standard Procedure
description: Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.
arm group label: Standard Procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 100 Years
last name: Saurabh Jamdar
role: Study Chair
affiliation: Manchester University NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sarcopenia