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

Completed

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: Prehabilitation; Procedure: Standard Procedure

• Registration Number: NCT03770117
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehabilitation	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
Standard Procedure	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.

Primary Outcome Measures

Name	Time	Method
CT Scan Comparison	Within last 5 years.	CT Scans from patients which underwent the Prehabilitation \& standard care will be compared.

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, Gtr Manchester, United Kingdom