Postoperative Artificial Nutrition After Pancreaticoduodenectomy (Nutri-DPC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01580527
First received: January 31, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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 %).


Condition Intervention
Pancreatic Disease
Procedure: Total parenteral nutrition
Procedure: Enteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Percentage of patients presenting one or several postoperative complications [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Data recorded during the period of hospitalization (an expected average of 3 weeks) and until control visit 3 months after surgery


Secondary Outcome Measures:
  • Nutritional status [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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

  • Infectious complications [ Time Frame: within the hospitalization time after surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    Percentage of patients presenting an infectious complication, and type of infectious complication

  • Evaluation of the severity of the complications [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    according to classification of Dindo-Clavien

  • Pancreatic fistulas [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    evaluation of the occurrence of pancreatic fistulas, grade B and C, in both groups of patients

  • Hemorrhagic complications [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    evaluation of the occurrence of hemorrhagic complications, grade B and C, in both groups of patients

  • gastroparesis [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    defined as the presence of the nasogastric probe 10 days after the surgery

  • Duration of hospital stay [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
  • Time frame of resumption of the intestinal bowel motion [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]
    daytime of resumption of flatulencies and\or stools

  • Time frame of resumption of the oral food and artificial nutrition weaning [ Time Frame: within the hospitalization time after the surgery (an expected average of 3 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580527

Contacts
Contact: Mustapha ADHAM, Professor +33 4 72 11 62.61 mustapha.adham@chu-lyon.fr

Locations
France
Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot Recruiting
LYON cedex 03, France, 69437
Principal Investigator: Mustapha ADHAM, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01580527     History of Changes
Other Study ID Numbers: 2010.627
Study First Received: January 31, 2012
Last Updated: April 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
postoperative artificial nutrition
parenteral nutrition
enteral nutrition
postoperative complications
cephalic pancreatoduodenectomy

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014