Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Last updated: March 28, 2025
Sponsor: University of Lausanne Hospitals
Overall Status: Completed

Phase

N/A

Condition

Diet And Nutrition

Weight Loss

Treatment

Early enteral nutrition

Clinical Study ID

NCT05042882
2021-00724
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: Early enteral nutrition
Phase:
Study Start date:
December 12, 2021
Estimated Completion Date:
January 13, 2025

Connect with a study center

  • Hôpital Cochin-Port Royal, AP-HP

    Paris,
    France

    Site Not Available

  • Regional Hospital of Lugano

    Lugano, Ticino
    Switzerland

    Site Not Available

  • Lausanne University Hospital (CHUV)

    Lausanne, Vaud
    Switzerland

    Site Not Available

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

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