Skip to main content
OpenTrials
Completed

NCT Number: NCT03770117

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, Gtr Manchester, M13 9WL, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Procedure

Participants who underwent Prehabilitation will have their CT scans analysed.

Standard Procedure

Procedure

Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.

Primary outcomes

  1. CT Scan Comparison

    Time frame: Within last 5 years.

    CT Scans from patients which underwent the Prehabilitation & standard care will be compared.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: SIPUP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.