Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy

Study Overview
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Brief Summary
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Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy. 96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. Enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated.

Detailed Description
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Background & aim: Pancreatoduodenectomy carries high morbidity rates even in high-volume centers. Postoperative complications often preclude or delay adequate oral nutrition and nutritional support may be required. However, the role of perioperative nutritional supplementation in well-nourished patients remains controversial. There are not any standard protocols for nutritional support after major upper gastrointestinal surgery in these patients and postoperative nutritional regimens depend mainly upon surgeon's or center preference. Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and enteral or parenteral nutrition is used to cover the daily caloric requirements during this period, although their role still remains questionable. The safety of early oral nutrition has been confirmed in the majority of gastrointestinal procedures. However, pancreatic surgeons are quite reluctant to advance oral diet within the first postoperative week after pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying syndrome. These two postoperative nutritional regimens, early oral vs. early enteral nutrition, have not been sufficiently evaluated in a prospective, randomized study. Material and Methods: 96 patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN group will receive standard enteral diet administered through a nasojejunal tube. The enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd postoperative day and oral intake will be advanced as tolerated. Purpose: The purpose of this study is to compare the influence of early enteral and oral nutrition on postoperative course and complications after pancreatoduodenectomy.

Official Title
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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Conditions
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Pancreatic Cancer, Cancer of the Duodenum, Cholangiocarcinoma, Chronic Pancreatitis

Intervention / Treatment
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* Other: Enteral nutrition
* Other: Oral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary periampullary tumor R0, R1 resection Chronic pancreatitis requiring pancreatoduodenectomy Exclusion Criteria: Metastatic tumor Locally unresectable tumor Previous gastric resection ASA IV-V Age under 18 years Preoperative complete parenteral or enteral feeding Immunosuppressive therapy before operation Severe malnutrition Lack of the patient's consent for the trial participation, feeding tube insertion or epidural analgesia

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN<br>early enteral nutrition with standard enteral formulas administered through a nasojejunal tube | Other: Enteral nutrition<br>* Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.<br>* Other names: standard enteral formula;|
| Active Comparator: PerOs<br>early oral nutrition with hospital diets and oral formulas | Other: Oral nutrition<br>* Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated<br>* Other names: oral diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of delayed gastric emptying |  | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall morbidity rate |  | 60 days after operation | 
| Perioperative mortality rate |  | 60 days after operation | 
| Postoperative hospital stay length |  | 60 days after operation | 
| Time to full oral nutrition |  | 60 days after operation | 
| Time to resolution of paralytic ileus |  | 7 days after operation | 
| Rehospitalization rate |  | 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periampullary tumor, Chronic pancreatitis, Pancreatoduodenectomy, Oral Nutrition, Enteral Nutrition