Enteral Nutrition for Post-Pancreatoduodenectomy Care

(NUTRIWHI Trial)

No longer recruiting at 3 trial locations

Overseen By Gaëtan-Romain Joliat, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Lausanne Hospitals

Disqualifiers: Language barrier, Psychological disorders, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early enteral nutrition (feeding through a tube) improves recovery after pancreas surgery compared to normal eating. Researchers seek to assess whether this method reduces complications, infections, and hospital readmissions in the short term. The focus is on patients undergoing elective pancreatoduodenectomy (a type of pancreas surgery) who are at nutritional risk, meaning they might not receive enough nutrients. Those who have already started tube feeding or have certain health issues (such as eating disorders or dementia) are not eligible. Participants will either begin tube feeding soon after surgery or follow a standard diet plan.

As an unphased trial, this study provides patients the chance to contribute to important research that could enhance post-surgical recovery strategies.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that early enteral nutrition is safe for post-pancreatoduodenectomy care?

Research has shown that starting to eat normally soon after surgery, such as a pancreatoduodenectomy (PD), is generally safe. This approach, known as early enteral nutrition (EEN), lowers the chances of complications, infections, and the need for hospital readmission. Patients receiving EEN often recover faster than those receiving all nutrition through an IV, known as total parenteral nutrition (TPN).

Patients have generally tolerated EEN well. It begins with a small amount of food, gradually increasing to help the body adjust, which reduces side effects. While some patients might experience minor digestive issues, these are usually manageable.

Overall, EEN appears to be a safe method to aid recovery after PD, with research supporting its benefits in reducing complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach of starting with oral nutrition after pancreatoduodenectomy, early enteral nutrition introduces nutrients directly into the digestive system from the first night after surgery. This method ensures that patients can receive adequate calories even if they're not ready for a full oral diet. By increasing the volume of nutrition gradually, this approach could potentially reduce recovery time and improve healing by providing consistent and tailored nutrition. Researchers are excited about this trial because it explores whether early enteral nutrition can enhance recovery outcomes compared to the traditional oral method.

What evidence suggests that early enteral nutrition is effective for post-pancreatoduodenectomy care?

Research shows that early nutrition through a feeding tube (EEN) can aid recovery after pancreas surgery, specifically pancreatoduodenectomy (PD). In this trial, one group of participants will receive EEN. Studies have found that EEN can shorten hospital stays, lower infection risks, and reduce readmission rates. It also results in fewer post-surgery complications compared to starting with regular eating. Previous research suggests that EEN might lower death rates and improve overall recovery, making it a promising option for better short-term outcomes after PD. ^{1 2 3 6 7}

Who Is on the Research Team?

Gaëtan-Romain Joliat, MD

Principal Investigator

University of Lausanne Hospitals

Markus Schäfer, MD

Principal Investigator

University of Lausanne Hospitals

Nicolas Demartines, MD

Principal Investigator

University of Lausanne Hospitals

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for elective pancreatoduodenectomy, at nutritional risk (NRS ≥3), and can give informed consent. It's not suitable for those with language barriers, psychological disorders affecting eating or decision-making, dementia, or if they've already started enteral feeding before surgery.

Inclusion Criteria

Your screening for nutritional risk indicates that you may have a higher chance of not getting enough nutrients.

I am scheduled for surgery to remove part of my pancreas and small intestine.

Signed informed consent.

Exclusion Criteria

I started tube feeding before my surgery.

I am unable to sign the consent form myself due to my condition.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either early enteral nutrition or standardized oral nutrition postoperatively

4 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Regular follow-up visits and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Early enteral nutrition

Trial Overview The study is testing whether early enteral nutrition (EEN) after pancreas surgery can improve recovery compared to just oral nutrition. It looks at how EEN affects postoperative complications, hospital stay length, readmission rates, quality of life and the body's response to stress and nutrition.

How Is the Trial Designed?

Group I: Early enteral nutrition Experimental Treatment 1 Intervention

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).

Group II: Oral nutrition Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Lausanne Hospitals

Lead Sponsor

Trials

219

Recruited

354,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9296100/

Early enteral vs. oral nutrition after Whipple procedure This study with its multicentric and randomized design will permit to establish if early postoperative enteral nutrition after PD improves ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05042882

Enteral vs. Oral Nutrition After Pancreatoduodenectomy Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X22001009

Early oral feeding after pancreatoduodenectomy The results suggest that EOF after PD does not increase postoperative complication rates, such as POPF and DGE, compared to EN and TPN with no increase in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6405366/

Effect of early and delay starting of enteral feeding in post- ... They concluded that early enteral feeding reduces mortality, morbidity and the length of hospital stay.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X19305891

A meta-analysis of the effect of early enteral nutrition ... Early enteral nutrition (EEN) has been considered to be more effective than total parenteral nutrition (TPN) for the early recovery of patients after many ...

6. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/01000/early_oral_feeding_versus_nasojejunal_early.25.aspx

Early oral feeding versus nasojejunal early enteral nutrition ... This study compared the safety and feasibility of early oral feeding (EOF) with nasojejunal early enteral nutrition (NJEEN) after PD.

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00387-6/fulltext

Supplemental parenteral nutrition within an enhanced ... Based on the results of this study, we expect that an ERAS protocol with early oral feeding and no supplemental artificial nutrition will become the new ...