Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Not Applicable

Completed

• Conditions: Pancreaticoduodenectomy; Malnutrition; Postoperative Complications
• Interventions: Dietary Supplement: Early enteral nutrition

• Registration Number: NCT05042882
• Lead Sponsor: University of Lausanne Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-13
• Study Start: 2021-12-12
• Primary Completion: 2025-01-13
• Study Completion: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early enteral nutrition	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).

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication Index	Postoperative day 90	Index measuring all complications for a patient

Secondary Outcome Measures

Name	Time	Method
Severe postoperative complications	Postoperative day 90	Dindo-Clavien \>II
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
Resting energy expenditure	On postoperative day 5	Indirect calorimetry
Body composition	Preoperatively and on the day when patients leave the hospital after the operation	Bioelectrical impedance analysis
Metabolic response to enteral nutrition	Preoperatively and twice weekly during the first postoperative week	Laboratory results
Muscular measure	Preoperatively and on the day when patients leave the hospital after the operation	Handgrip strength measure
Specific complications after pancreatoduodenectomy	Postoperative day 90	SSI, DGE, POPF, PPH, biliary fistula, gastrojejunal anastomosis fistula, pancreatitis

Trial Locations

Locations (3)

Hôpital Cochin-Port Royal, AP-HP; 🇫🇷 Paris, France

Regional Hospital of Lugano; 🇨🇭 Lugano, Ticino, Switzerland

Lausanne University Hospital (CHUV); 🇨🇭 Lausanne, Vaud, Switzerland