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)
Abstract 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 ther...
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2020-06-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-020-04366-3 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Caroline Gronnier Cécile Chambrier Alain Duhamel Benoît Dervaux Denis Collet Delphine Vaudoyer Jean-Marc Régimbeau Jacques Jougon Jérémie Théréaux Gil Lebreton Julie Veziant Alain Valverde Pablo Ortega-Deballon François Pattou Muriel Mathonnet Julie Perinel Laura Beyer-Berjot David Fuks Philippe Rouanet Jérémie H. Lefevre Pierre Cattan Sophie Deguelte Bernard Meunier Jean-Jacques Tuech Patrick Pessaux Nicolas Carrere Ephrem Salame Eleonor Benaim Bertrand Dousset Simon Msika Christophe Mariette Guillaume Piessen on behalf of FRENCH association |
spellingShingle |
Caroline Gronnier Cécile Chambrier Alain Duhamel Benoît Dervaux Denis Collet Delphine Vaudoyer Jean-Marc Régimbeau Jacques Jougon Jérémie Théréaux Gil Lebreton Julie Veziant Alain Valverde Pablo Ortega-Deballon François Pattou Muriel Mathonnet Julie Perinel Laura Beyer-Berjot David Fuks Philippe Rouanet Jérémie H. Lefevre Pierre Cattan Sophie Deguelte Bernard Meunier Jean-Jacques Tuech Patrick Pessaux Nicolas Carrere Ephrem Salame Eleonor Benaim Bertrand Dousset Simon Msika Christophe Mariette Guillaume Piessen on behalf of FRENCH association 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) Trials Enteral nutrition Parenteral nutrition Conservative treatment Upper gastrointestinal fistula Randomized controlled trial |
author_facet |
Caroline Gronnier Cécile Chambrier Alain Duhamel Benoît Dervaux Denis Collet Delphine Vaudoyer Jean-Marc Régimbeau Jacques Jougon Jérémie Théréaux Gil Lebreton Julie Veziant Alain Valverde Pablo Ortega-Deballon François Pattou Muriel Mathonnet Julie Perinel Laura Beyer-Berjot David Fuks Philippe Rouanet Jérémie H. Lefevre Pierre Cattan Sophie Deguelte Bernard Meunier Jean-Jacques Tuech Patrick Pessaux Nicolas Carrere Ephrem Salame Eleonor Benaim Bertrand Dousset Simon Msika Christophe Mariette Guillaume Piessen on behalf of FRENCH association |
author_sort |
Caroline Gronnier |
title |
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) |
title_short |
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) |
title_full |
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) |
title_fullStr |
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) |
title_full_unstemmed |
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) |
title_sort |
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) |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-06-01 |
description |
Abstract 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. |
topic |
Enteral nutrition Parenteral nutrition Conservative treatment Upper gastrointestinal fistula Randomized controlled trial |
url |
http://link.springer.com/article/10.1186/s13063-020-04366-3 |
work_keys_str_mv |
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doaj-d4b7e166d2974ab5a932a60f73d034442020-11-25T02:46:59ZengBMCTrials1745-62152020-06-0121111010.1186/s13063-020-04366-3Enteral 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)Caroline Gronnier0Cécile Chambrier1Alain Duhamel2Benoît Dervaux3Denis Collet4Delphine Vaudoyer5Jean-Marc Régimbeau6Jacques Jougon7Jérémie Théréaux8Gil Lebreton9Julie Veziant10Alain Valverde11Pablo Ortega-Deballon12François Pattou13Muriel Mathonnet14Julie Perinel15Laura Beyer-Berjot16David Fuks17Philippe Rouanet18Jérémie H. Lefevre19Pierre Cattan20Sophie Deguelte21Bernard Meunier22Jean-Jacques Tuech23Patrick Pessaux24Nicolas Carrere25Ephrem Salame26Eleonor Benaim27Bertrand Dousset28Simon Msika29Christophe Mariette30Guillaume Piessen31on behalf of FRENCH associationDepartment of Visceral Surgery, Centre Médico-chirurgical MagellanDepartment of Nutrition and Intestinal Rehabilitation, Lyon Sud University HospitalPôle de Santé Publique, Department of Biostatistic, University Hospital of LilleMaison Régionale de la Recherche Clinique, Hospitalière et Universitaire - CHRU de LilleDepartment of Visceral Surgery, Centre Médico-chirurgical MagellanDepartment of Visceral Surgery, Lyon Sud University HospitalDepartment of Visceral Surgery, Amiens University HospitalDepartment of Thoracic Surgery, Centre Médico-chirurgical Magellan, Bordeaux University HospitalDepartment of Visceral Surgery, Hospital Center Regional UniversityDepartment of Visceral Surgery, Caen University HospitalDepartment of Visceral Surgery, Gabriel-Montpied HospitalDepartment of Visceral Surgery, Diaconesses HospitalDepartment of Visceral Surgery, University Hospital Dijon BourgogneDepartment of Visceral and Endocrine Surgery, Huriez University HospitalDepartment of Visceral Surgery, Dupuytren University HospitalDepartment of Visceral Surgery, Edouard Herriot University HospitalDepartment of Visceral Surgery, Hôpital NordDepartment of Visceral Surgery, Institut Mutualiste MontsourisDepartment of Visceral Surgery, Institut Regional Cancer MontpellierDepartment of Visceral Surgery, Saint-Antoine University HospitalDepartment of Visceral Surgery, Saint-Louis University HospitalDepartment of Visceral Surgery, Robert Debré University HospitalDepartment of Visceral Surgery, Pontchaillou University HospitalDepartment of Visceral SurgeryDepartment of Visceral Surgery, Nouvel Hôpital CivilDepartment of Visceral Surgery, Purpan University HospitalDepartment of Visceral SurgeryDepartment of Visceral Surgery, Gustave Roussy InstituteDepartment of Visceral Surgery, Cochin HospitalDepartment of Visceral Surgery, Bichat HospitalDepartment of Digestive and Oncological Surgery, Lille University HospitalDepartment of Digestive and Oncological Surgery, Lille University HospitalAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04366-3Enteral nutritionParenteral nutritionConservative treatmentUpper gastrointestinal fistulaRandomized controlled trial |