NUTRIWHI: Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT05042882

Collaborator

(none)

128

Enrollment

Locations

Arms

36.7

Anticipated Duration (Months)

42.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy Malnutrition Postoperative Complications	Dietary Supplement: Early enteral nutrition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 12, 2021

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early enteral nutrition 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).	Dietary Supplement: Early enteral nutrition Enteral nutrition via nasojejunal tube
No Intervention: Oral nutrition 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.

Arm

Intervention/Treatment

Experimental: Early enteral nutrition

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).

Dietary Supplement: Early enteral nutrition

Enteral nutrition via nasojejunal tube

No Intervention: Oral nutrition

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.

Outcome Measures

Primary Outcome Measures

Comprehensive Complication Index [Postoperative day 90]
Index measuring all complications for a patient

Secondary Outcome Measures

Severe postoperative complications [Postoperative day 90]
Dindo-Clavien >II
Specific complications after pancreatoduodenectomy [Postoperative day 90]
SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis
Length of stay [Up to 90 days]
From operation day to hospital discharge
Readmission [Postoperative day 90]
Hospital readmission due to surgical complications
Patients' quality of life [Preoperatively and at 30 and 90 days after the operation]
EORTC questionnaires
Metabolic response to enteral nutrition [Preoperatively and twice weekly during the first postoperative week]
Laboratory results
Body composition [Preoperatively and on the day when patients leave the hospital after the operation]
Bioelectrical impedance analysis
Muscular measure [Preoperatively and on the day when patients leave the hospital after the operation]
Handgrip strength measure
Resting energy expenditure [On postoperative day 5]
Indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atrium Health Carolinas Medical Center	Charlotte	North Carolina	United States	28203
2	Regional Hospital of Lugano	Lugano	Ticino	Switzerland
3	Lausanne University Hospital (CHUV)	Lausanne	Vaud	Switzerland