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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
144
Enteral nutrition via nasojejunal tube
Hôpital Cochin-Port Royal, AP-HP
Paris, France
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland
Regional Hospital of Lugano
Lugano, Canton Ticino, Switzerland
Comprehensive Complication Index
Index measuring all complications for a patient
Time frame: Postoperative day 90
Severe postoperative complications
Dindo-Clavien \>II
Time frame: Postoperative day 90
Specific complications after pancreatoduodenectomy
SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis
Time frame: Postoperative day 90
Length of stay
From operation day to hospital discharge
Time frame: Up to 90 days
Readmission
Hospital readmission due to surgical complications
Time frame: Postoperative day 90
Patients' quality of life
EORTC questionnaires
Time frame: Preoperatively and at 30 and 90 days after the operation
Metabolic response to enteral nutrition
Laboratory results
Time frame: Preoperatively and twice weekly during the first postoperative week
Body composition
Bioelectrical impedance analysis
Time frame: Preoperatively and on the day when patients leave the hospital after the operation
Muscular measure
Handgrip strength measure
Time frame: Preoperatively and on the day when patients leave the hospital after the operation
Resting energy expenditure
Indirect calorimetry
Time frame: On postoperative day 5
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