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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: Prehabilitation
* Procedure: Standard Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients treated by pancreatic resection Surgery for malignancy Patients aged over 16 CT scans available for assessment Exclusion criteria Patients scheduled for fast-track pancreatic resection as part of the jaundice pathway Aged under 16 Patients not undergoing pancreatic resection

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehabilitation<br>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 | Procedure: Prehabilitation<br>* Participants who underwent Prehabilitation will have their CT scans analysed.<br>|
| Standard Procedure<br>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. | Procedure: Standard Procedure<br>* Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Cancer, Sarcopenia, Cachexia, Prehabilitation, Pancreatoduodenectomy