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

NHS Foundation Trust

Status: Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: Standard Procedure; Procedure: Prehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT03770117

B00101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

113 participants in 2 patient groups

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: 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

Treatment:

Procedure: Prehabilitation

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.

Treatment:

Procedure: Standard Procedure