Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease (SIPUP)

January 15, 2021 updated by: Manchester University NHS Foundation Trust

A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gtr Manchester
      • Manchester, Gtr Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have had a pancreatoduodenectomy. Control group will have had standard care and these CT Scan results will be compared with those who have undergone prehabilitation.

Description

Inclusion criteria

  1. Patients treated by pancreatic resection
  2. Surgery for malignancy
  3. Patients aged over 16
  4. CT scans available for assessment

Exclusion criteria

  1. Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway
  2. Aged under 16
  3. Patients not undergoing pancreatic resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prehabilitation

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:

  1. Assessment for malnutrition and nutritional support dependent on the outcome
  2. Optimisation of management of pancreatic exocrine insufficiency
  3. Assessment of muscle mass and strength
  4. Individually tailored, goal directed exercise regimen under the care of physiotherapy
Participants who underwent Prehabilitation will have their CT scans analysed.
Standard Procedure
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.
Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT Scan Comparison
Time Frame: Within last 5 years.
CT Scans from patients which underwent the Prehabilitation & standard care will be compared.
Within last 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Saurabh Jamdar, Manchester University NHS Foundation trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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