Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreaticoduodenectomy, Malnutrition, Postoperative Complications

Intervention / Treatment
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* Dietary Supplement: Early enteral nutrition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early enteral nutrition<br>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<br>* Enteral nutrition via nasojejunal tube<br>|
| No Intervention: Oral nutrition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index | Index measuring all complications for a patient | Postoperative day 90 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutrition, Enteral nutrition, Pancreatoduodenectomy, Whipple operation, Pancreas surgery, Morbidity