Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial).
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 08 2021
01 08 2021
Historique:
pubmed:
17
11
2020
medline:
11
9
2021
entrez:
16
11
2020
Statut:
ppublish
Résumé
To establish the optimal time to start oral refeeding in mild and moderate acute pancreatitis (AP) to reduce hospital length-of-stay (LOS) and complications. Oral diet is essential in mild and moderate AP. The greatest benefits are obtained if refeeding starts early; however, the definition of "early" remains controversial. This multicenter, randomized, controlled trial (NCT03829085) included patients with a diagnosis of mild or moderate AP admitted consecutively to 4 hospitals from 2017 to 2019. Patients were randomized into 2 treatment groups: immediate oral refeeding (IORF) and conventional oral refeeding (CORF). The IORF group (low-fat-solid diet initiated immediately after hospital admission) was compared to CORF group (progressive oral diet was restarted when clinical and laboratory parameters had improved) in terms of LOS (primary endpoint), pain relapse, diet intolerance, complications, and, hospital costs. One hundred and thirty one patients were included for randomization. The mean LOS for the IORF and CORF groups was 3.4 (SD ± 1.7) and 8.8 (SD ± 7.9) days, respectively (P < 0.001). In the CORF group alone, pain relapse rate was 16%. There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7€/patient in the IORF than CORF group. IORF is safe and feasible in mild and moderate AP, resulting in significantly shorter LOS and cost savings, without causing adverse effects or complications.
Sections du résumé
OBJECTIVE
To establish the optimal time to start oral refeeding in mild and moderate acute pancreatitis (AP) to reduce hospital length-of-stay (LOS) and complications.
SUMMARY BACKGROUND DATA
Oral diet is essential in mild and moderate AP. The greatest benefits are obtained if refeeding starts early; however, the definition of "early" remains controversial.
METHODS
This multicenter, randomized, controlled trial (NCT03829085) included patients with a diagnosis of mild or moderate AP admitted consecutively to 4 hospitals from 2017 to 2019. Patients were randomized into 2 treatment groups: immediate oral refeeding (IORF) and conventional oral refeeding (CORF). The IORF group (low-fat-solid diet initiated immediately after hospital admission) was compared to CORF group (progressive oral diet was restarted when clinical and laboratory parameters had improved) in terms of LOS (primary endpoint), pain relapse, diet intolerance, complications, and, hospital costs.
RESULTS
One hundred and thirty one patients were included for randomization. The mean LOS for the IORF and CORF groups was 3.4 (SD ± 1.7) and 8.8 (SD ± 7.9) days, respectively (P < 0.001). In the CORF group alone, pain relapse rate was 16%. There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7€/patient in the IORF than CORF group.
CONCLUSIONS
IORF is safe and feasible in mild and moderate AP, resulting in significantly shorter LOS and cost savings, without causing adverse effects or complications.
Identifiants
pubmed: 33196485
pii: 00000658-202108000-00013
doi: 10.1097/SLA.0000000000004596
doi:
Banques de données
ClinicalTrials.gov
['NCT03829085']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
255-263Informations de copyright
Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
Références
Greenberg JA, Hsu J, Bawazeer M, et al. Clinical practice guideline: management of acute pancreatitis. Can J Surg 2016; 59:128–140.
Working Group, IAP/APA., Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology 2013; 13: (4 Suppl 2): e1–e15.
Párnicsky A, Abu-El-Haija M, Husain S, et al. EPC/HPSG evidence-based guidelines for the management of pediatric pancreatitis. Pancreatology 2018; 18:146–160.
Tenner S, Baillie J, DeWitt J, et al. American college of gastroenterology. American College of Gastroenterology Guideline: management of acute pancreatitis. Am J Gastroenterol 2013; 108:1400–1415.
Corckett SD, Wani S, Gardner TB, et al. American gastroenterological association institute guideline on initial management of acute pancreatitis. Gastroentoroloy 2018; 154:1096–1101.
Isaji S, Takada T, Mayumi T, et al. Revised Japanese guidelines for the management of acute pancreatitis 2015: revised concepts and updated points. J Hepatobiliary Pancreat Sci 2015; 22:433–445.
Boadas J, Balsells J, Busquets J, et al. Valoración y tratamiento de la pancreatitis aguda. Documento de posicionamiento de la Societat Catalana de Digestologia, Societat Catalana de Cirurgia y Societat Catalana de Pàncreas. Gastroenterol Hepatol 2015; 38:82–96.
Lodewijks PJ, Besselink MG, Witteman BJ, et al. Nutrition in acute pancreratitis: a critical review. Expert Rev Gastroenterol Hepatol 2016; 10:571–580.
Roberts KM, Nanikian-Nelms M, Ukleja A, et al. Nutritional aspects of acute pancreatitis. Gastroenterol Clin North Am 2018; 47:77–94.
Oláh A, Romics L. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol 2014; 20:16123–16131.
Petrov MS, van Santvoort HC, Besselink MG, et al. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol 2007; 102:2079–2084.
Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr 2009; 101:787–793.
Petrov MS, Mcllroy K, Grayson L, et al. Early nasogastric the feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr 2013; 32:697–703.
Petrov MS, McIlroy K, Grayson L, et al. Early nasogastric tube feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr 2013; 32:697–703.
Meng J, Zhang H, Lu B, et al. The optimal timing of enteral nutrition its effect on the prognosis of acute pancreatitis: a propensity score matched cohort study. Pancreatology 2017; 17:651–657.
Feng P, He Ch, Liao G, et al. Early enteral nutrition versus delayed enteral nutrition in acute pancreatitis: a PRISMA-compliant systematic review and meta-analysis. Medicine 2017; 96:e8648.
Vaughn VM, Shuster D, Rogers MAM, et al. Early versus delayed feeding in patients with acute pancreatitis: a systematic review. Ann Intern Med 2017; 166:883–892.
Stimac D, Poropat G, Hauser G, et al. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: a randomized clinical trial. Pancreatology 2016; 16:523–528.
Eckerwall GE, Tingstedt BB, Bergenzaun PE, et al. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery—a randomized clinical study. Clin Nutr 2007; 26:758–763.
Teich N, Aghdassi A, Fisher J, et al. Optimal timing of oral refeeding in mild acute pancreatitis: results of an open randomized multicenter trial. Pancreas 2010; 39:1088–1092.
Li J, Xue GJ, Liu YL, et al. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas 2013; 42:88–91.
Lariño-Noia J, Lindkvist B, Iglesias-García J, et al. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology 2014; 14:167–173.
Zhao XL, Zhu SF, Xue GJ, et al. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition 2015; 31:171–175.
Khan S, Ranjha WA, Tariq H, et al. Efficacy of early oral refeeding in patients of mild acute pancreatitis. Pac J Med Sci 2017; 33:899–902.
Nelly DM, Kelly EG, Clarke M, et al. Systematic review with meta-analysis. Nasogastric nutrition is efficacious in severe acute pancreatitis: a systematic review and meta-analysis. Br J Nutr 2014; 112:1769–1778.
Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit 2014; 17:2327–2335.
Horibe M, Nishizawa T, Suzuki H, et al. Timing of oral refeeding in acute pancreatitis: a systematic review and meta-analysis. United European Gastroenterol J 2016; 4:725–732.
Jacobson BC, Vander Vliet MB, Hughes MD, et al. A prospective, randomized trial of clear liquids vs. low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol 2007; 5:946–951.
Sathiaraj E, Murthy S, Mansard MJ, et al. Clinical trial: oral feeding with a soft diet compared with celar liquid diet as initial meal in mild acute pancreatitis. Aliment Pharmacol Ther 2008; 15:777–781.
Moraes JM, Felga GE, Chebli LA, et al. A full solid diet as the initial meal in mild acute pancreatitis is sabe and result in a shorter length of hospitalization: results from a prospective, randomized, controlled, double-blind clinical trial. J Clin Gastroenterol 2010; 44:517–522.
Rajkumar N, Karthikeyan VS, Ali SM, et al. Clear liquid diet vs soft diet as the initial meal in patients with mild acute pancreatitis: a randomized interventional trial. Nutr Clin Pract 2013; 28:365–370.
Meng WB, Li X, Li YM, et al. Three initial diets for management of mild acute pancreatitis: a meta-analysis. World J Gastroenterol 2011; 17:4235–4241.
Bevan MG, Asrani VM, Bharmal S, et al. Incidence and predictors of oral feeding intolerance in acute pancreatitis: a systematic review, meta-analysis, and meta-regresion. Clin Nutr 2017; 36:722–729.
Rinnienella E, Annetta MG, Serricchio ML, et al. Nutritional support in acute pancreatitis: from pchysiopathology to practice. An evidence-based approach. Our Rev Med Pharmacol Sci 2017; 21:421–432.
Bakker OJ, van Brunchot S, van Santvoort HC, et al. Early versus on-demand nasoenteric tube feeding in acute pancreatitis. N Engl J Med 2014; 371:1983–1993.
Greenberg JA, Hsu J, Bawazeer M, et al. Compliance with evidence-based guidelines in acute pancreatitis: an audit of practices in university of Toronto hospitals. J Gastontest Surg 2016; 20:392–400.
Dellinger EP, Forsmark CE, Layer P, et al. Determinant-based classification of acute pancreatitis severity: an international multidisciplinary consultation. Ann Surg 2012; 256:875–880.
Banks PA, Bollen TL, Dervenis C, et al. Classification of acute pancreatitis -2012: revision or the Atlanta classification and definitions by international consensus. Gut 2013; 62:102–111.
Zubia-Olaskoaga F, Maravi-Poma E, Urreta-Barallobre I, et al. Comparison between revised Atlanta classification and determinant-based classification for acute pancreatitis in intensive care medicine. Why do not use a modified determinant-based classification? Cris Care Med 2016; 44:910–917.
Moher D, Hopewelll S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. Int J Surg 2012; 10:28–55.
Bevan MG, Asrani V, Petrov MS. The oral refeeding trilemma of acute pancreatitis: what, when and who? Expert Rev Gastroenterol Hepatol 2015; 9:1305–1312.
Xiao AY, Tan ML, Wu LM, et al. Global incidence and mortality of pancreatic diseases: a systematic review, meta-analysis, and meta-regression of population-based cohort studies. Lancet Gastroenterol Hepatol 2016; 1:45–55.
Petrov MS, Yadav D. Global epidemiology and holistic prevention of pancreatitis. Nat Rev Gastroenterol Hepatol 2019; 16:174–184.
Valverde-López F, Wilcox CM, Redondo-Cerezo E. Evaluation and management of acute pancreatitis in Spain. Gastroenterol Hepatol 2018; 41:618–628.
Ragnarsson T, Andersson R, Ansari D, et al. Acute biliary pancreatitis - focus on recurrence rate and costs when current guidelines are not complied. Scand J Gastroenterol 2017; 52:264–269.