Enteral Nutrition for Post-Pancreatoduodenectomy Care

(NUTRIWHI Trial)

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

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates if providing nutrients directly to the stomach or small intestine soon after pancreas surgery can help patients recover better. It focuses on patients with pancreas cancer, chronic pancreatitis, or those needing pancreas surgery, who often have poor nutrition. The goal is to see if this method reduces complications and improves overall recovery.

Research Team

Markus Schäfer, MD

Principal Investigator

University of Lausanne Hospitals

Gaëtan-Romain Joliat, MD

Principal Investigator

University of Lausanne Hospitals

Nicolas Demartines, MD

Principal Investigator

University of Lausanne Hospitals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+