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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

January 31, 2012
April 17, 2012
March 2011
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01580527 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Postoperative Artificial Nutrition After Pancreaticoduodenectomy
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 %).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pancreatic Disease
  • Procedure: Total parenteral nutrition
    Total parenteral nutrition in postoperative of pancreaticoduodenectomy
  • Procedure: Enteral nutrition
    Early enteral nutrition in postoperative of pancreaticoduodenectomy
  • Active Comparator: total parenteral nutrition
    Intervention: Procedure: Total parenteral nutrition
  • Experimental: Early enteral nutrition
    Intervention: Procedure: Enteral nutrition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mustapha ADHAM, Professor +33 4 72 11 62.61 mustapha.adham@chu-lyon.fr
France
 
NCT01580527
2010.627
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP