Postoperative Artificial Nutrition After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits. The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition. A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively). Hypothesis : The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).

Official Title
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A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

Conditions
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Pancreatic Disease

Intervention / Treatment
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* Procedure: Total parenteral nutrition
* Procedure: Enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients more than 18 years of age. Pancreatic surgery by pancreaticoduodenectomy. Patient affiliated to a mode of the social security or receiving of such a mode. Having given written informed consent prior to any procedure related to the study Exclusion Criteria: ASA score ≥4 Pregnant women Patient who cannot give written informed consent. Concomitant participation in a biomedical study being able to interfere with this research Patient less than 18 years of age or more than 18 years of age, protected by the Law, under guardianship

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 |
| --- | --- |
| Active Comparator: total parenteral nutrition<br> | Procedure: Total parenteral nutrition<br>* Total parenteral nutrition in postoperative of pancreaticoduodenectomy<br>|
| Experimental: Early enteral nutrition<br> | Procedure: Enteral nutrition<br>* Early enteral nutrition in postoperative of pancreaticoduodenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting one or several postoperative complications | Data recorded during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | weight, BMI, Index of Nutritional Risk, blood albumin and prealbumin, during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery | 90 days | 
| Infectious complications | Percentage of patients presenting an infectious complication, and type of infectious complication | within the hospitalization time after surgery (an expected average of 3 weeks) | 
| Evaluation of the severity of the complications | according to classification of Dindo-Clavien | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| Pancreatic fistulas | evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| Hemorrhagic complications | evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| gastroparesis | defined as the presence of the nasogastric probe 10 days after the surgery | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| Duration of hospital stay |  | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| Time frame of resumption of the intestinal bowel motion | daytime of resumption of flatulencies and\or stools | within the hospitalization time after the surgery (an expected average of 3 weeks) | 
| Time frame of resumption of the oral food and artificial nutrition weaning |  | within the hospitalization time after the surgery (an expected average of 3 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative artificial nutrition, parenteral nutrition, enteral nutrition, postoperative complications, cephalic pancreatoduodenectomy