Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Study Overview
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Brief Summary
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Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Detailed Description
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Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial. To evaluate whether early enteral nutrition may be decreased the postoperative complications To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy To determine the optimal method for postoperative nutritional support

Official Title
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A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Conditions
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Pancreas Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

Intervention / Treatment
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* Procedure: Enteral Feeding and Total Parental Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periampullar carcinoma Pancreaticoduonectomy KARNOFSKY PERFORMANCE SCALE > 70 No history of Major operation Exclusion Criteria: Creatinine level>3mg/L Ascitis/portal hypertension New York Heart Association class>3 COPD Preoperative Radiotheraly/chemotherapy Unresectable primary cancer Palliative surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>1. Enteral Feeding | Procedure: Enteral Feeding and Total Parental Support<br>* Enteral Feeding : 20ml/hr on POD1 Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)<br>* Other names: until full nutritional goal (25Kcal/Kg);|
| No Intervention: 2<br>Total Parental support | Procedure: Enteral Feeding and Total Parental Support<br>* Enteral Feeding : 20ml/hr on POD1 Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)<br>* Other names: until full nutritional goal (25Kcal/Kg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of early postoperative enteral feeding |  | Postoperative 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the nutritional status |  | Postoperative 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support