Enteral vs. Oral Nutrition After Pancreatoduodenectomy (NUTRIWHI)

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Postoperative Complications; Malnutrition; Pancreaticoduodenectomy

Treatments: Dietary Supplement: Early enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05042882

2021-00724

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Early enteral nutrition

Experimental group

Description:

Intervention group: enteral nutrition from the first postoperative night until 50% of caloric requirements are covered by oral nutrition. Enteral nutrition will start at a flow of 250 ml/12h. If tolerated, enteral nutrition will be increased to 500 ml/12h on postoperative day 1, 750 ml/12h on postoperative day 2, and 1000 ml/12h on postoperative day 3. A hypercaloric enteral nutrition will be used (Isosource Energy Fibre or similar).

Treatment:

Dietary Supplement: Early enteral nutrition

Oral nutrition

No Intervention group

Description:

Control group: patients will receive standardized oral nutrition. The night after the operation, patients will be allowed to have free drinks. On postoperative day 1, they will receive bouillons, creams, yogurts, and drinks \>2 l. On postoperative day 2, they will receive a light diet. On postoperative day 3, they will receive half portion of normal diet and on postoperative day 4 normal diet.