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001-es BibID:	BIBFORM136206
035-os BibID:	(wos)001710787300001 (scopus)105035333535
Első szerző:	Márta Katalin
Cím:	High versus gradually increasing energy nutrition in the early phase of acute pancreatitis (GOULASH) : a multicentre double-blind randomised clinical trial / Katalin Márta, Marie Anne Engh, Áron Vincze, Bálint Erőss, Péter J. Hegyi, Alexandra Mikó, Ferenc Izbéki, Mária Papp, Péter Mátrai, Zsolt Abonyi-Tóth, Nándor Faluhelyi, Andrea Szentesi, Péter Hegyi, the Goulash Trial Group
Dátum:	2026
ISSN:	0017-5749
Megjegyzések:	ABSTRACT Background Acute pancreatitis (AP) is among the most common gastrointestinal diseases requiring hospitalisation, often with severe outcomes and no disease-specific therapy. Nutritional support has been proven to improve outcome, but little is known regarding optimal timing and composition. Objective This clinical trial aimed to compare high (30 kcal/kg/day, high energy (HE)) versus gradually increasing energy (0 increased to 30 kcal/kg/day over 4 days, low energy (LE)) strategies for enteral nutritional support in AP. Design This was a multicentric, double-blind, randomised clinical trial, enrolling patients with AP regardless of predicted severity (January 2017 to April 2023). The primary outcome was a combination of mortality and severe acute pancreatitis (Revised Atlanta Criteria); secondary outcomes included severity, rate of infection, organ failure and pain relapse. Interim analysis was planned after 50% enrolment. The Benjamini-Hochberg false discovery rate (FDR) method was used to correct p value for multiple testing. Results The trial was stopped early after enrolling 636 patients. Interim analysis showed that the primary outcome showed no difference between groups in the modified intention-to-treat (mITT) population (HE: 28/312, 9.0% vs LE: 18/307, 5.7%, p(uncorrected/ corrected)=0.19/0.42). Secondary outcomes showed no difference in the mITT analysis. Without correction for multiplicity testing, results favoured a low gradual energy strategy in terms of organ failure (HE: 52/312, 16.7% vs LE: 28/307, 9.1%, p(uncorrected)=0.007) and pain relapse (80/312, 27.1% vs 54/307, 19.0% p(uncorrected)=0.03) but showed no differences between groups after correction for multiple testing (p=0.13 and p=0.23, respectively). It was determined that the superiority of the intervention would not be shown even with an increased sample size, and thus the trial was terminated based on a post hoc decision on ethics and futility. Conclusion Based on this early terminated trial, a high-energy strategy for early nutrition in pancreatitis does not decrease mortality/severity, but potentially increases organ failure and pain relapse rate.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Gut. - 75 (2026), p. 995-1002. -
További szerzők:	Engh, Marie Anne Vincze Áron Erőss Bálint Hegyi Péter Jenő (belgyógyász) Mikó Alexandra Izbéki Ferenc Papp Mária (1975-) (belgyógyász, gasztroenterológus) Mátrai Péter Abonyi-Tóth Zsolt Faluhelyi Nándor Szentesi Andrea Hegyi Péter Jr. (belgyógyász) Vitális Zsuzsanna (1963-) (belgyógyász, gasztroenterológus) Fehér Krisztina Eszter (1991-) (orvos) the Goulash Trial Group
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI
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