What side effects are associated with this type of intervention?

Early Enteral Nutrition (EEN) is commonly used to provide nutritional support directly to the gastrointestinal tract, especially in postoperative patients. Known side effects of EEN include gastrointestinal discomfort such as bloating, diarrhea, and nausea. There is also a risk of aspiration pneumonia if the patient is not positioned correctly during feeding. Additionally, metabolic complications like refeeding syndrome can occur if nutritional support is initiated too rapidly in severely malnourished patients. Overall, while EEN can improve recovery and reduce complications, careful monitoring is essential to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved various enteral nutrition products designed to provide nutritional support directly to the gastrointestinal tract, which is similar to the concept of Early Enteral Nutrition (EEN). These products include specialized formulas that cater to different nutritional needs and conditions, such as high-protein, high-calorie, and fiber-enriched formulas. Additionally, the FDA has approved medications like metoclopramide and domperidone to enhance gastrointestinal motility, which can support the effectiveness of enteral nutrition by improving gastric emptying and nutrient absorption. These treatments aim to improve recovery and reduce complications in malnourished patients, particularly in the postoperative period.

What other types of research exist?

Promising novel alternatives to Early Enteral Nutrition (EEN) for malnutrition patients include: 1) Total Parenteral Nutrition (TPN), which provides nutrients intravenously and is useful when enteral feeding is not feasible. 2) Fish oil-based lipid emulsions, such as Omegaven, which have shown benefits in reversing parenteral nutrition-associated liver disease. 3) Branched-chain amino acids (BCAAs) supplementation, which has been effective in improving nutritional status post-surgery. 4) Multimodal interventions combining nutritional supplements like eicosapentaenoic acid (EPA) with pharmacological agents such as megestrol acetate and celecoxib, which have shown promise in managing cancer cachexia and improving lean body mass.

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Dietary Supplement

Enteral Nutrition for Post-Pancreatoduodenectomy Care (NUTRIWHI Trial)

N/A

Recruiting

Led By Gaëtan-Romain Joliat, MD

Research Sponsored by University of Lausanne Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient ≥18 years old.

Be older than 18 years old

Must not have

Enteral feeding already initiated preoperatively.

Patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively and on the day when patients leave the hospital after the operation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't detailed here, generally enteral nutrition might cause digestive issues like nausea or bloating. There could also be risks associated with tube placement such as infection or irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I started tube feeding before my surgery.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperatively and at 30 and 90 days after the operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperatively and at 30 and 90 days after the operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively and at 30 and 90 days after the operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comprehensive Complication Index

Secondary study objectives

Body composition

Length of stay

Metabolic response to enteral nutrition

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early enteral nutritionExperimental Treatment1 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 nutritionActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Early enteral nutrition

2016

N/A

~120

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Early Enteral Nutrition (EEN) works by providing essential nutrients directly to the gastrointestinal tract early in the postoperative period, which helps improve recovery and reduce complications. This method is particularly important for malnutrition patients as it ensures timely delivery of nutrients, supports immune function, promotes healing, and maintains gut integrity. By addressing these critical needs, EEN helps prevent infections and other complications, ultimately enhancing the overall nutritional status and recovery of malnutrition patients.