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PancreaticoduodenectomyNUTRIWHINCT05042882

Enteral vs. Oral Nutrition After Pancreatoduodenectomy

A study testing Early enteral nutrition in people with Pancreaticoduodenectomy and Malnutrition, run by University of Lausanne Hospitals at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Early enteral nutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
3 sitesin 2 countries
Study dates
12 Dec 2021to 13 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Switzerland2 sites

  • Lausanne University Hospital (CHUV)

    Lausanne, Canton of Vaud

  • Regional Hospital of Lugano

    Lugano, Canton Ticino

Other trials in Switzerland

France1 site

  • Hôpital Cochin-Port Royal, AP-HP

    Paris

Other trials in France

About this study

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

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.

Being tested
Early enteral nutrition
Keywords
Enteral nutrition, Oral nutrition, Pancreatoduodenectomy, Whipple operation, Pancreas surgery, Morbidity
Medical subject headings
Malnutrition, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early enteral nutritionDietary supplement

    Enteral nutrition via nasojejunal tube

Study groups in NCT05042882
Study groupRoleWhat they receive
Early enteral nutritionExperimentalIntervention 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).
Receives: Dietary Supplement: Early enteral nutrition
Oral nutritionNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comprehensive Complication Index

    Index measuring all complications for a patient

    Measured: Postoperative day 90

Secondary outcomes (9)

  1. Severe postoperative complications

    Dindo-Clavien >II

    Measured: Postoperative day 90

  2. Specific complications after pancreatoduodenectomy

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

    Measured: Postoperative day 90

  3. Length of stay

    From operation day to hospital discharge

    Measured: Up to 90 days

  4. Readmission

    Hospital readmission due to surgical complications

    Measured: Postoperative day 90

  5. Patients' quality of life

    EORTC questionnaires

    Measured: Preoperatively and at 30 and 90 days after the operation

  6. Metabolic response to enteral nutrition

    Laboratory results

    Measured: Preoperatively and twice weekly during the first postoperative week

  7. Body composition

    Bioelectrical impedance analysis

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

  8. Muscular measure

    Handgrip strength measure

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

  9. Resting energy expenditure

    Indirect calorimetry

    Measured: On postoperative day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start12 Dec 2021
  3. Primary completion13 Jan 2025
  4. Study completion13 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042882
Sponsor's protocol ID
2021-00724
Acronym
NUTRIWHI
Status last verified
Mar 2025
First submitted
30 Aug 2021
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Joliat GR, Martin D, Labgaa I, Uldry E, Melloul E, Halkic N, Cristaudi A, Majno-Hurst P, Pozza G, Fuks D, Marchese U, Demartines N, Schafer M. Early Enteral vs Oral Postoperative Nutrition After Pancreatoduodenectomy: The NUTRIWHI Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):575-582. doi: 10.1001/jamasurg.2026.1048.

    PubMed 42018334

  • Joliat GR, Martin D, Labgaa I, Melloul E, Uldry E, Halkic N, Fotsing G, Cristaudi A, Majno-Hurst P, Vrochides D, Demartines N, Schafer M. Early enteral vs. oral nutrition after Whipple procedure: Study protocol for a multicentric randomized controlled trial (NUTRIWHI trial). Front Oncol. 2022 Jun 28;12:855784. doi: 10.3389/fonc.2022.855784. eCollection 2022.

    PubMed 35865476

Questions about this trial

What is this clinical trial studying?

A study testing Early enteral nutrition in people with Pancreaticoduodenectomy and Malnutrition, run by University of Lausanne Hospitals at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive Complication Index (time frame: Postoperative day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05042882, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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