Postoperative Artificial Nutrition After Pancreaticoduodenectomy

Pancreatic Disease Clinical Trial

— Nutri-DPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01580527
• Other study ID #: 2010.627
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2012
• Last updated: April 17, 2012
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2012
• Source: Hospices Civils de Lyon
• Contact: Mustapha ADHAM, Professor
• Phone: +33 4 72 11 62.61
• Email: mustapha.adham[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 %).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases

Intervention

Procedure:
• Total parenteral nutrition
Total parenteral nutrition in postoperative of pancreaticoduodenectomy
• Enteral nutrition
Early enteral nutrition in postoperative of pancreaticoduodenectomy

Locations

Country	Name	City	State
France	Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Duration of hospital stay		within the hospitalization time after the surgery (an expected average of 3 weeks)	No
Secondary	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)	No
Secondary	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)	No