Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Malnutrition Clinical Trial

— NUTRIWHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042882
• Other study ID #: 2021-00724
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2021
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: University of Lausanne Hospitals
• Contact: Gaëtan-Romain Joliat, MD
• Phone: +41795564293
• Email: gaetan.joliat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Pancreaticoduodenectomy
• Postoperative Complications

Intervention

Dietary Supplement:
• Early enteral nutrition
Enteral nutrition via nasojejunal tube

Locations

Country	Name	City	State
France	Hôpital Cochin-Port Royal, AP-HP	Paris
Switzerland	Lausanne University Hospital (CHUV)	Lausanne	Vaud
Switzerland	Regional Hospital of Lugano	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

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