In English: liver and pancreatic tumours. In Dutch: lever en pancreas tumoren.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Liver tumour (benign tumour, primary cancer, suspicion of a malignancy, or colorectal liver metastasis), pancreatic malignancy, premalignant pancreatic tumour or the suspicion of a pancreatic malignancy requiring resection - Undergoing elective liver (segmental resection or hemihepatectomy) or pancreatic surgery (pancreaticoduodenectomy, subtotal or total pancreatectomy) - Having a life expectancy of more than 6 months - Has given consent to participate in the study - VSAQ score =7 METs - Anaerobic threshold <11 ml/kg/min at the first CPET - Will be operated at MST, UMCG or MMC - Living in Enschede, Oldenzaal, Losser, Lonneker or Glanerbrug (in case of inclusion in MST)
Exclusion criteria
Exclusion criteria: - Not capable to cycle - Not capable to perform a CPET - Meeting the absolute and/or relative exclusion criteria from the CPET protocol used in MST or UMCG. These criteria are based on the criteria from the American Thoracic Society and American College of Chest Physicians Statement on CPET.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the (preliminary) effectiveness of the four-week home-based multimodal prehabilitation program in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, to improve aerobic capacity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are: - To evaluate the feasibility of a four-week home-based multimodal prehabilitation program in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, as measured by adherence/compliance, adverse events, motivation, patient appreciation - Does the prehabilitation program improve preoperative quality of life, as measured by the Short Form 36 (SF-36)? - Does the prehabilitation program affect other CPET values reflecting aerobic capacity, such as the highest measured oxygen uptake (VO2peak), and oxygen uptake efficiency slope (OUES)? - What is the (preliminary) effect of the prehabilitation program on the physical fitness of an individual patient, as assessed by results on the CPET, steep ramp test, and Lode ergometer data? - What is the (preliminary) effect of prehabilitation on the immune system, by measuring IL-6, IL-8, IL-10, CRP, and TNF-a after the first and prior to the second CPET? - What is the (preliminary) effect of prehabilitation on skeletal muscle metabolic function (energy metabolism)? - Data on operative intervention, perioperative outcomes (i.e. morbidity, mortality, length of hospital stay) and postoperative progress will also be collected, to describe the perioperative course in patients after elective liver or pancreatic resection. | — |
Contacts
Medisch Spectrum Twente