Malnutrition, Pancreaticoduodenectomy, Postoperative Complications
Conditions
Keywords
Enteral nutrition, Oral nutrition, Pancreatoduodenectomy, Whipple operation, Pancreas surgery, Morbidity
Brief summary
Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition. The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.
Interventions
DIETARY_SUPPLEMENTEarly enteral nutrition
Enteral nutrition via nasojejunal tube
Sponsors
University of Lausanne Hospitals
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
* Patient scheduled for elective open pancreatoduodenectomy. * Patient ≥18 years old. * Patient at nutritional risk, i.e., with Nutrition Risk Screening (NRS) ≥3. * Signed informed consent.
Exclusion criteria
* Patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients). * Enteral feeding already initiated preoperatively. * Language barrier. * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders (i.e., eating disorders and bipolar disorders), or dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index | Postoperative day 90 | Index measuring all complications for a patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific complications after pancreatoduodenectomy | Postoperative day 90 | SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis |
| Length of stay | Up to 90 days | From operation day to hospital discharge |
| Readmission | Postoperative day 90 | Hospital readmission due to surgical complications |
| Patients' quality of life | Preoperatively and at 30 and 90 days after the operation | EORTC questionnaires |
| Severe postoperative complications | Postoperative day 90 | Dindo-Clavien \>II |
| Body composition | Preoperatively and on the day when patients leave the hospital after the operation | Bioelectrical impedance analysis |
| Muscular measure | Preoperatively and on the day when patients leave the hospital after the operation | Handgrip strength measure |
| Resting energy expenditure | On postoperative day 5 | Indirect calorimetry |
| Metabolic response to enteral nutrition | Preoperatively and twice weekly during the first postoperative week | Laboratory results |
Countries
France, Switzerland
Outcome results
None listed