Home monitoring vs hospitalization for mild acute pancreatitis. A pilot randomized controlled clinical trials.


Journal

Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R

Informations de publication

Date de publication:
19 May 2023
Historique:
medline: 21 6 2023
pubmed: 19 6 2023
entrez: 19 6 2023
Statut: ppublish

Résumé

Acute pancreatitis is a high-incidence benign disease. In 2009, it was the second highest cause of total hospital stays, the largest contributor to aggregate costs (approximately US$ 7000.00 per hospitalization), and the fifth leading cause of in-hospital deaths in the United States. Although almost 80% of acute pancreatitis cases are mild (usually requiring short-term hospitalization and without further complications), severe cases can be quite challenging.Classifications, scores, and radiological criteria have been developed to predict disease severity and outcome accurately; however, in-hospital care remains of widespread use, regardless of disease severity. A recent Turkish study reported that mild acute pancreatitis can be effectively and safely managed with home monitoring. Although the optimal timing for oral refeeding remains controversial and could cast some doubt on the feasibility of home monitoring, some guidelines already advocate for starting it within 24 hours.The present clinical trial aims to assess whether home monitoring is effective, safe and non-inferior to hospitalization for managing mild acute pancreatitis. This will be a multicenter open-label randomized (1:1) controlled clinical trial to assess the efficacy and safety of home monitoring compared to in-hospital care for mild acute pancreatitis. All patients coming to the emergency department with suspected acute pancreatitis will be screened for enrollment. The main variable will be treatment failure (Yes/No) within the first 7 days after randomization. Acute pancreatitis implies a high economic burden in healthcare systems worldwide. Recent evidence suggests that mild disease can be safely and effectively treated with home monitoring. This approach may produce considerable cost savings and positively impact patients' quality of life. We expect the results to show that home monitoring is effective and not inferior to hospitalization for managing mild acute pancreatitis and that the economic costs are lower, kickstarting similar trials throughout the world, optimizing the use of limited healthcare budgets, and improving patients' quality of life.

Identifiants

pubmed: 37335696
doi: 10.1097/MD.0000000000033853
pii: 00005792-202305190-00012
pmc: PMC10194650
doi:

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e33853

Informations de copyright

Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.

Déclaration de conflit d'intérêts

The authors have no conflicts of interest to disclose.

Références

Clin Nutr. 2007 Dec;26(6):758-63
pubmed: 17719703
Psychother Psychosom. 2022;91(1):8-35
pubmed: 34991091
Pancreatology. 2014 May-Jun;14(3):174-8
pubmed: 24854612
Pancreatology. 2022 Mar;22(2):175-184
pubmed: 34876385
Lancet. 2015 Jul 4;386(9988):85-96
pubmed: 25616312
Gastroenterol Hepatol. 2018 Dec;41(10):618-628
pubmed: 30149943
Am J Gastroenterol. 2010 Feb;105(2):435-41; quiz 442
pubmed: 19861954
Saudi J Gastroenterol. 2019 Jan-Feb;25(1):14-19
pubmed: 30226482
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Heliyon. 2022 Feb 01;8(2):e08852
pubmed: 35198753
Pancreatology. 2017 Sep - Oct;17(5):669-674
pubmed: 28851510
Gut. 2013 Jan;62(1):102-11
pubmed: 23100216
JAMA. 2021 Jan 26;325(4):382-390
pubmed: 33496779
JAMA. 2016 Feb 23;315(8):801-10
pubmed: 26903338
Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15
pubmed: 24054878
J Pain. 2019 Mar;20(3):245-263
pubmed: 30099210

Auteurs

Maria Sorribas (M)

Digestive and General Surgery Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.

Thiago Carnaval (T)

Pharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.

Núria Peláez (N)

Digestive and General Surgery Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.

Luis Secanella (L)

Digestive and General Surgery Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.

Silvia Salord (S)

Gastroenterology Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.

Sònia Sarret (S)

Home Hospitalization Unit, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.

Sebastián Videla (S)

Pharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.
Clinical Research Support Unit (HUB·IDIBELL), Clinical Pharmacology Department, Bellvitge University Hospital, L´Hospitalet DE Llobregat, Barcelona, Spain.

Juli Busquets (J)

Digestive and General Surgery Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Research Group of Hepato-Biliary and Pancreatic Diseases, Institut d'Investigació Biomèdica de Bellvitge - IDIBELL, University of Barcelona, L'Hospitalet DE Llobregat, Barcelona, Spain.
Departament de Ciències Clíniques, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB), Barcelona, Spain.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH