Early enteral nutrition
Dietary SupplementEnteral nutrition via nasojejunal tube
NCT Number: NCT05042882
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hôpital Cochin-Port Royal, AP-HP, Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enteral nutrition via nasojejunal tube
Time frame: Postoperative day 90
Index measuring all complications for a patient
Time frame: Postoperative day 90
Dindo-Clavien >II
Time frame: Postoperative day 90
SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis
Time frame: Up to 90 days
From operation day to hospital discharge
Time frame: Postoperative day 90
Hospital readmission due to surgical complications
Time frame: Preoperatively and at 30 and 90 days after the operation
EORTC questionnaires
Time frame: Preoperatively and twice weekly during the first postoperative week
Laboratory results
Time frame: Preoperatively and on the day when patients leave the hospital after the operation
Bioelectrical impedance analysis
Time frame: Preoperatively and on the day when patients leave the hospital after the operation
Handgrip strength measure
Time frame: On postoperative day 5
Indirect calorimetry
University of Lausanne Hospitals
Other
Early Enteral vs. Oral Nutrition After Whipple Procedure: a Multicentric Randomized Controlled Trial
Acronym: NUTRIWHI
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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.
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