Postoperative Artificial Nutrition After Pancreaticoduodenectomy (Nutri-DPC)

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

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 %).

Study Overview

• Status: Unknown
• Conditions: Pancreatic Disease
• Intervention / Treatment: Procedure: Total parenteral nutrition; Procedure: Enteral nutrition

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustapha ADHAM, Professor; Phone Number: +33 4 72 11 62.61; Email: mustapha.adham@chu-lyon.fr

Study Locations

• France
  • LYON cedex 03, France, 69437
    • Recruiting
    • Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot
    • Principal Investigator: Mustapha ADHAM, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: total parenteral nutrition	Procedure: Total parenteral nutrition; Total parenteral nutrition in postoperative of pancreaticoduodenectomy
Experimental: Early enteral nutrition	Procedure: Enteral nutrition; Early enteral nutrition in postoperative of pancreaticoduodenectomy

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2012
• Last Update Submitted That Met QC Criteria: April 17, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: enteral nutrition; postoperative complications; parenteral nutrition; postoperative artificial nutrition; cephalic pancreatoduodenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 2010.627