Postoperative Artificial Nutrition After Pancreaticoduodenectomy
Nutri-DPC
A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
1 other identifier
interventional
220
1 country
1
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 %).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 19, 2012
April 1, 2012
3 years
January 31, 2012
April 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Nutritional status
90 days
Infectious complications
within the hospitalization time after surgery (an expected average of 3 weeks)
Evaluation of the severity of the complications
within the hospitalization time after the surgery (an expected average of 3 weeks)
Pancreatic fistulas
within the hospitalization time after the surgery (an expected average of 3 weeks)
Hemorrhagic complications
within the hospitalization time after the surgery (an expected average of 3 weeks)
- +4 more secondary outcomes
Study Arms (2)
total parenteral nutrition
ACTIVE COMPARATOREarly enteral nutrition
EXPERIMENTALInterventions
Total parenteral nutrition in postoperative of pancreaticoduodenectomy
Early enteral nutrition in postoperative of pancreaticoduodenectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot
Lyon, 69437, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
April 19, 2012
Study Start
March 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 19, 2012
Record last verified: 2012-04