Enteral Nutrition After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Pancreaticoduodenectomy (PD) is the treatment of choice for resectable periampullary cancer. PD is still associated with a relatively a high incidence of delayed gastric emptying. And, there are no acknowledged strategies to avoid DGE. Several feeding strategies have been investigated to cope with this problem. However, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. The purpose of this study is to determine the effect of nutrition support methods on DGE after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition. Patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (EN group), or Saline administration (Saline group), or oral intake only (Natural control). 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 Saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. Oral intake will not be restricted in all three group.

Official Title
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Effect of Enteral Nutrition on Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

Conditions
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Cholangiocarcinoma, Cancer of Pancreas, Cancer of Duodenum, Ampulla of Vater Cancer

Intervention / Treatment
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* Other: Early enteral nutrition
* Other: Saline
* Device: nasojejunal tube insertion
* Other: Oral intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients underwent selective pancreaticoduodenectomy Patients ≥18 years old and ≤80 years old Having given written informed consent Exclusion Criteria: Previous gastric resection or intestinal reconstruction Preoperative complete parenteral or enteral feeding ASA score ≥4 Pregnant women Severe malnutrition Patient who cannot give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Early enteral nutrition<br>Nasojejunal tube insertion was done intraopratively. Early enteral nutrition with standard enteral formulas administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | Other: Early enteral nutrition<br>* Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted.<br>Device: nasojejunal tube insertion<br> <br> * Other names: Naso-jejunal tube will be placed intraoperatively.;Other: Oral intake<br>* Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.<br>|
| Placebo Comparator: Saline Group<br>Nasojejunal tube insertion was done intraopratively. Saline was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | Other: Saline<br>* Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will.<br>Device: nasojejunal tube insertion<br> <br> * Other names: Naso-jejunal tube will be placed intraoperatively.;|
| Other: ERAS Group<br>Nasojejunal tube insertion was done intraopratively. None was administered through the nasojejunal tube. Oral intake was encouraged as long as the patient can tolerate. | Device: nasojejunal tube insertion<br> <br> * Other names: Naso-jejunal tube will be placed intraoperatively.;Other: Oral intake<br>* Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident rate of delayed gastric emptying | DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay length |  | 60 days | 
| Overall morbidity rate |  | 30 days | 
| Postoperative mortality rate |  | 30 days | 
| Rehospitalization rate |  | 60 days | 
| Infectious complications |  | 30 days | 
| Evaluation of the severity of the complications | according to classification of Dindo-Clavien | 30 days | 
| Pancreatic fistulas | evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients | 30 days | 
| Hemorrhagic complications | evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients | 30 days | 
| Maximum Plasma Concentration fasting plasma GLP-1 level | Fasting plasma concentration GLP-1 level was monitored | Preoperative day 1, Postoperative day 1, Postoperative day 4, Postoperative day 7 |