Clinical trial NCT03770117: Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
Official title: A Pilot Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Pancreas
Cancer
Sarcopenia
Cachexia
Prehabilitation
Pancreatoduodenectomy
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2018-12-10
Enrollment: 113
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CT Scan Comparison
timeFrame: Within last 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Gtr Manchester
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Saurabh Jamdar
role: STUDY_CHAIR
References: