Titre :

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study)

Auteur(s) :

Gronnier, Caroline [Auteur]
Chambrier, Cécile [Auteur]
Duhamel, Alain [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Dervaux, Benoît [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Collet, Denis [Auteur]
Vaudoyer, Delphine [Auteur]
Régimbeau, Jean-Marc [Auteur]
Jougon, Jacques [Auteur]
Théréaux, Jérémie [Auteur]
Lebreton, Gil [Auteur]
Veziant, Julie [Auteur]
Valverde, Alain [Auteur]
Ortega-Deballon, Pablo [Auteur]
Pattou, François [Auteur]
Recherche translationnelle sur le diabète - U 1190 [RTD]
Mathonnet, Muriel [Auteur]
Perinel, Julie [Auteur]
Beyer-Berjot, Laura [Auteur]
Fuks, David [Auteur]
Rouanet, Philippe [Auteur]
Lefevre, Jérémie H. [Auteur]
Cattan, Pierre [Auteur]
Deguelte, Sophie [Auteur]
Meunier, B. [Auteur]
Tuech, Jean-Jacques [Auteur]
Pessaux, Patrick [Auteur]
Institut de Recherche sur les Maladies Virales et Hépatiques [IVH]
Carrere, Nicolas [Auteur]
Salame, Ephrem [Auteur]
Benaim, Eleonor [Auteur]
Dousset, Bertrand [Auteur]
Msika, Simon [Auteur]
Mariette, Christophe [Auteur]
Piessen, Guillaume [Auteur]
Hétérogénéité, Plasticité et Résistance aux Thérapies des Cancers = Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 [CANTHER]

Titre de la revue :

Trials

Éditeur :

BioMed Central

Date de publication :

2020

ISSN :

1745-6215

Mot(s)-clé(s) en anglais :

Conservative treatment
Enteral nutrition
Parenteral nutrition
Randomized controlled trial
Upper gastrointestinal fistula

Discipline(s) HAL :

Sciences du Vivant [q-bio]/Médecine humaine et pathologie

Résumé en anglais : [en]

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and ...
Lire la suite >BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.Lire moins >

Langue :

Anglais

Vulgarisation :

Non

Commentaire :

This research program is funded by the French Ministry of Health through Programme Hospitalier de Recherche Clinique 2016.

Collections :

• Centre d'Infection et d'Immunité de Lille (CIIL) - U1019 - UMR 9017

Source :

Harvested from HAL

Date de dépôt :

2024-02-17T04:29:20Z