Postoperative Artificial Nutrition After Pancreaticoduodenectomy (Nutri-DPC)
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About
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 %).
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
220 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Mustapha ADHAM, Professor
Data sourced from clinicaltrials.gov
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