Clinical trial NCT01580527: Postoperative Artificial Nutrition After Pancreaticoduodenectomy
Official title: A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Disease
Keywords: postoperative artificial nutrition
parenteral nutrition
enteral nutrition
postoperative complications
cephalic pancreatoduodenectomy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 %).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients presenting one or several postoperative complications
timeFrame: 90 days
Secondary outcomes:
measure: Nutritional status
timeFrame: 90 days
measure: Infectious complications
timeFrame: within the hospitalization time after surgery (an expected average of 3 weeks)
measure: Evaluation of the severity of the complications
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: Pancreatic fistulas
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: Hemorrhagic complications
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: gastroparesis
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: Duration of hospital stay
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: Time frame of resumption of the intestinal bowel motion
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
measure: Time frame of resumption of the oral food and artificial nutrition weaning
timeFrame: within the hospitalization time after the surgery (an expected average of 3 weeks)
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot
Study officials:
References: