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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.
Patient scheduled for elective open pancreatoduodenectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperatively and on the day when patients leave the hospital after the operation
Awards & highlights
NUTRIWHI Trial Summary
This trial is testing whether early enteral nutrition (EEN) can reduce postoperative morbidity after pancreatoduodenectomy (PD) compared to oral nutrition.
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.Check my eligibility
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.See study design
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.
NUTRIWHI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for surgery to remove part of my pancreas and small intestine.
NUTRIWHI Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comprehensive Complication Index
Secondary outcome measures
Body composition
Length of stay
Metabolic response to enteral nutrition
+6 moreNUTRIWHI 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
Find a Location
Who is running the clinical trial?
University of Lausanne HospitalsLead Sponsor
208 Previous Clinical Trials
350,917 Total Patients Enrolled
2 Trials studying Postoperative Complications
350 Patients Enrolled for Postoperative Complications
Nicolas Demartines, MDStudy ChairLausanne University Hospital
6 Previous Clinical Trials
658 Total Patients Enrolled
1 Trials studying Postoperative Complications
200 Patients Enrolled for Postoperative Complications
Markus Schäfer, MDStudy DirectorLausanne University Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I started tube feeding before my surgery.I am unable to sign the consent form myself due to my condition.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.You do not speak the language that the study is conducted in.
Research Study Groups:
This trial has the following groups:- Group 1: Early enteral nutrition
- Group 2: Oral nutrition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants currently being recruited for this medical experiment?
"Clinicaltrials.gov confirms that this clinical trial, originally posted on December 12th 2021, is accepting participants. This listing was last updated on the same day."
Answered by AI
How many participants are currently engaged in this research endeavor?
"Indeed, the details posted to clinicaltrials.gov verify that this investigation is actively searching for participants with an initial posting date of December 12th 2021 and a recent update on the same day. This research project requires 128 individuals from one medical site."
Answered by AI
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