Sarcopenia, Pancreatic Cancer
Conditions
Keywords
morbimortality, Prehabilitaion, pancreatic surgery, cephalic duodenopancreatectomy
Brief summary
Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes. The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.
Interventions
4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
DIETARY_SUPPLEMENTOral Impact
perioperative immunonutrition by ORAL IMPACT
Sponsors
Groupement Interrégional de Recherche Clinique et d'Innovation
Santelys Association
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing pancreaticoduodenectomy for cancer * Sarcopenic status
Exclusion criteria
* Age younger than 18 years * Medical contraindications including cardiovascular disease or clinically significant vascular disease * Physical inability to exercise * Emergent surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative severe pancreatic fistula (Grade B and C) | at 90 days | Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | at 1 year and at 3 years | — |
| Program acceptance measure by Modified ACCEPT© questionnaire | at 30 days | — |
| Rate of program completion | at 30 days | self questionnaire to measure opinion with respect of rehabilitation program |
| Rate of Severe postoperative complications | at 90 days | Grade \> IIIa (Clavien-Dindo classification) |
| Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45) | at 30 days | French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index) |
| Quality of life by EORTC-QLQc30 scale | at 1 month, 3 months, 6 months and at 1 year | The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL. |
| Satisfaction questionnaire by EVAN-G | at 30 days | EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems. |
Countries
France
Contacts
Primary ContactMehdi ELAMRANI, MD
Outcome results
None listed