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Completed

NCT Number: NCT05042882

Enteral vs. Oral Nutrition After Pancreatoduodenectomy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin-Port Royal, AP-HP, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early enteral nutrition

Dietary Supplement

Enteral nutrition via nasojejunal tube

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: Postoperative day 90

    Index measuring all complications for a patient

Secondary outcomes

  1. Severe postoperative complications

    Time frame: Postoperative day 90

    Dindo-Clavien >II

  2. Specific complications after pancreatoduodenectomy

    Time frame: Postoperative day 90

    SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis

  3. Length of stay

    Time frame: Up to 90 days

    From operation day to hospital discharge

  4. Readmission

    Time frame: Postoperative day 90

    Hospital readmission due to surgical complications

  5. Patients' quality of life

    Time frame: Preoperatively and at 30 and 90 days after the operation

    EORTC questionnaires

  6. Metabolic response to enteral nutrition

    Time frame: Preoperatively and twice weekly during the first postoperative week

    Laboratory results

  7. Body composition

    Time frame: Preoperatively and on the day when patients leave the hospital after the operation

    Bioelectrical impedance analysis

  8. Muscular measure

    Time frame: Preoperatively and on the day when patients leave the hospital after the operation

    Handgrip strength measure

  9. Resting energy expenditure

    Time frame: On postoperative day 5

    Indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Early Enteral vs. Oral Nutrition After Whipple Procedure: a Multicentric Randomized Controlled Trial

Acronym: NUTRIWHI

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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