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]
Hôpital Haut-Lévêque - CHU de Bordeaux [Centre médico chirurgical Magellan]
Chambrier, Cécile [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Duhamel, Alain [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
DERVAUX, Benoit [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Collet, Denis [Auteur]
Hôpital Haut-Lévêque - CHU de Bordeaux [Centre médico chirurgical Magellan]
Vaudoyer, Delphine [Auteur]
Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS]
Régimbeau, Jean-Marc [Auteur]
CHU Amiens-Picardie
Jougon, Jacques [Auteur]
Hôpital Haut-Lévêque - CHU de Bordeaux [Centre médico chirurgical Magellan]
Théréaux, Jéremie [Auteur]
Centre Hospitalier Régional Universitaire de Brest [CHRU Brest]
Lebreton, Giles [Auteur]
Université de Caen Normandie [UNICAEN]
Veziant, Julie [Auteur]
Service Chirurgie Digestive et Hépatobiliaire [CHU Clermont-Ferrand]
Valverde, Alain [Auteur]
Groupe Hospitalier Diaconesses Croix Saint-Simon
Ortega-Deballon, Pablo [Auteur]
Département de chirurgie thoracique et digestive [CHU de Dijon]
Pattou, Francois [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Mathonnet, Muriel [Auteur]
Hôpital Dupuytren [CHU Limoges]
Perinel, Julie [Auteur]
Hôpital Edouard Herriot [CHU - HCL]
Beyer-Berjot, Laura [Auteur]
Hôpital Nord [CHU - APHM]
Fuks, David [Auteur]
Institut Mutualiste de Montsouris [IMM]
Rouanet, Philippe [Auteur]
UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle [ICM]
Lefevre, Jéremie H. [Auteur]
Centre de Recherche Saint-Antoine [UMRS893]
Cattan, Pierre [Auteur]
Hopital Saint-Louis [AP-HP] [AP-HP]
Deguelte, Sophie [Auteur]
Hôpital Robert Debré
Meunier, Bernard [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Tuech, Jean-Jacques [Auteur]
CHU Rouen
Pessaux, Patrick [Auteur]
Nouvel Hôpital Civil de Strasbourg
Carrere, Nicolas [Auteur]
Chirurgie Générale et Digestive [Purpan]
Salame, Ephrem [Auteur]
CHU Trousseau [Tours]
Benaim, Eleonor [Auteur]
Institut Gustave Roussy [IGR]
Dousset, Bertrand [Auteur]
Hôpital Cochin [AP-HP]
Msika, Simon [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Mariette, Christophe [Auteur]
Service d'oncologie médicale (CHRU Lille)
Piessen, Guillaume [Auteur]
Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277
mariette [Auteur]

Titre de la revue :

Trials

Nom court de la revue :

Trials

Numéro :

21

Pagination :

448

Date de publication :

2020-06-06

ISSN :

1745-6215

Mot(s)-clé(s) en anglais :

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

Discipline(s) HAL :

Sciences du Vivant [q-bio]

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 ...
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

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277
• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
• Recherche translationnelle sur le diabète (RTD) - U1190

Date de dépôt :

2023-11-15T08:46:17Z
2023-12-22T08:56:51Z
2023-12-22T08:58:58Z