Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

Párniczky, Andrea; Mosztbacher, Dóra; Zsoldos, Fanni; Tóth, Anna Zsófia; Lásztity, Natália; Hegyi, Péter

doi:10.1159/000441353

Cited by 20 publications

(10 citation statements)

References 39 publications

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“…The APR launched in 2011 by the Hungarian Pancreatic Study Group is an international prospective registry for patients suffering from AP. Besides pancreatic registries, HPSG has already organized five registered clinical trials to investigate AP with the acronyms PREPAST (Dubravcsik et al, 2015), APPLE (Parniczky et al, 2016), PINEAPPLE (Zsoldos et al, 2016), GOULASH (Marta et al, 2017), and EASY (Hritz and Hegyi, 2015) and has submitted three further pre-study protocols: GOULASH PLUS (follow-up to the GOULASH study), EMILY (endoscopic sphincterotomy for delaying cholecystectomy in mild acute biliary pancreatitis), and LIFESPAN (lifestyle, prevention, and risk of AP).…”

Section: Methodsmentioning

confidence: 99%

Multiple Hits in Acute Pancreatitis: Components of Metabolic Syndrome Synergize Each Other’s Deteriorating Effects

et al. 2019

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IntroductionThe incidence of acute pancreatitis (AP) and the prevalence of metabolic syndrome (MetS) are growing worldwide. Several studies have confirmed that obesity (OB), hyperlipidemia (HL), or diabetes mellitus (DM) can increase severity, mortality, and complications in AP. However, there is no comprehensive information on the independent or joint effect of MetS components on the outcome of AP. Our aims were (1) to understand whether the components of MetS have an independent effect on the outcome of AP and (2) to examine the joint effect of their combinations.MethodsFrom 2012 to 2017, 1435 AP cases from 28 centers were included in the prospective AP Registry. Patient groups were formed retrospectively based on the presence of OB, HL, DM, and hypertension (HT). The primary endpoints were mortality, severity, complications of AP, and length of hospital stay. Odds ratio (OR) with 95% confidence intervals (CIs) were calculated.Results1257 patients (55.7 ± 17.0 years) were included in the analysis. The presence of OB was an independent predictive factor for renal failure [OR: 2.98 (CI: 1.33–6.66)] and obese patients spent a longer time in hospital compared to non-obese patients (12.1 vs. 10.4 days, p = 0.008). HT increased the risk of severe AP [OR: 3.41 (CI: 1.39–8.37)], renal failure [OR: 7.46 (CI: 1.61–34.49)], and the length of hospitalization (11.8 vs. 10.5 days, p = 0.020). HL increased the risk of local complications [OR: 1.51 (CI: 1.10–2.07)], renal failure [OR: 6.4 (CI: 1.93–21.17)], and the incidence of newly diagnosed DM [OR: 2.55 (CI: 1.26–5.19)]. No relation was found between the presence of DM and the outcome of AP. 906 cases (mean age ± SD: 56.9 ± 16.7 years) had data on all four components of MetS available. The presence of two, three, or four MetS factors increased the incidence of an unfavorable outcome compared to patients with no MetS factors.ConclusionOB, HT, and HL are independent risk factors for a number of complications. HT is an independent risk factor for severity as well. Components of MetS strongly synergize each other’s detrimental effect. It is important to search for and follow up on the components of MetS in AP.

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Section: Methodsmentioning

confidence: 99%

Multiple Hits in Acute Pancreatitis: Components of Metabolic Syndrome Synergize Each Other’s Deteriorating Effects

et al. 2019

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“…To achieve our aims we (i) developed an electronic data registry for patients (www. pancreas.hu), (ii) published the currently available evidencebased medicine (EBM) guidelines [9][10][11][12][13], (iii) established specific study sessions including the pancreatic cancer one, (iv) and organized multicenter clinical trials [14][15][16][17].…”

Section: Methodsmentioning

confidence: 99%

Pancreatic Cancer: Multicenter Prospective Data Collection and Analysis by the Hungarian Pancreatic Study Group

Lakatos

Balázs

Kui

et al. 2016

JGLD

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Background & Aims: Pancreatic cancer is a devastating disease with poor prognosis. There is very limited information available regarding the epidemiology and treatment strategies of pancreatic cancer in Central Europe. The purpose of the study was to prospectively collect and analyze data of pancreatic cancer in the Hungarian population. Methods: The Hungarian Pancreatic Study Group (HPSG) organized prospective, uniform data collection. Altogether 354 patients were enrolled from 14 Hungarian centers. Results: Chronic pancreatitis was present in 3.7% of the cases, while 33.7% of the patients had diabetes. Family history for pancreatic cancer was positive in 4.8%. The most frequent presenting symptoms included pain (63.8%), weight loss (63%) and jaundice (52.5%). The reported frequency of smoking and alcohol consumption was lower than expected (28.5% and 27.4%, respectively). The majority of patients (75.6%) were diagnosed with advanced disease. Most patients (83.6%) had a primary tumor located in the pancreatic head. The histological diagnosis was ductal adenocarcinoma in 90.7% of the cases, while neuroendocrine tumor was present in 5.3%. Biliary stent implantation was performed in 166 patients, 59.2% of them received metal stents. Primary tumor resection was performed in 60 (16.9%) patients. Enteral or biliary bypass was done in 35 and 49 patients, respectively. In a multivariate Cox-regression model, smoking status and presence of gemcitabine-based chemotherapy were identified as independent predictors for overall survival. Conclusion: We report the first data from a large cohort of Hungarian pancreatic cancer patients. We identified smoking status and chemotherapy as independent predictors in this cohort. Abbreviations: EBM: evidence-based medicine; EPI: exocrine pancreatic insufficiency; FNAB: fine needle aspiration biopsy; HPSG: Hungarian Pancreatic Study Group; MDCT: multi-detector computed tomography; OS: overall survival; PC: pancreatic cancer; RPP: Registry for Pancreatic Patients

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“…We faced several difficulties during our review: (1) APP is still underdiagnosed, thus decreasing the possibility of performing clinical trials[ 45 ]; (2) the number of studies on the management of these patients is very low, and there is still only a small number of studies focused on understanding the characteristics of the disease[ 46 ]; (3) the studies have not focused on the early management of the patients; the groups were therefore not separated; and (4) finally, but very importantly, the methods sections and the quality of data presentation in these articles are very low. Consequently, in many cases, it was impossible to obtain quality analysable data from the manuscripts for a proper broad-spectrum meta-analysis[ 37 - 39 ].…”

Section: Discussionmentioning

confidence: 99%

Restoration of energy level in the early phase of acute pediatric pancreatitis

Mosztbacher¹,

Farkas²,

Solymár³

et al. 2017

WJG

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Acute pancreatitis (AP) is a serious inflammatory disease with rising incidence both in the adult and pediatric populations. It has been shown that mitochondrial injury and energy depletion are the earliest intracellular events in the early phase of AP. Moreover, it has been revealed that restoration of intracellular ATP level restores cellular functions and defends the cells from death. We have recently shown in a systematic review and meta-analysis that early enteral feeding is beneficial in adults; however, no reviews are available concerning the effect of early enteral feeding in pediatric AP. In this minireview, our aim was to systematically analyse the literature on the treatment of acute pediatric pancreatitis. The preferred reporting items for systematic review (PRISMA-P) were followed, and the question was drafted based on participants, intervention, comparison and outcomes: P: patients under the age of twenty-one suffering from acute pancreatitis; I: early enteral nutrition (per os and nasogastric- or nasojejunal tube started within 48 h); C: nil per os therapy; O: length of hospitalization, need for treatment at an intensive care unit, development of severe AP, lung injury (including lung oedema and pleural effusion), white blood cell count and pain score on admission. Altogether, 632 articles (PubMed: 131; EMBASE: 501) were found. After detailed screening of eligible papers, five of them met inclusion criteria. Only retrospective clinical trials were available. Due to insufficient information from the authors, it was only possible to address length of hospitalization as an outcome of the study. Our mini-meta-analysis showed that early enteral nutrition significantly (SD = 0.806, P = 0.034) decreases length of hospitalization compared with nil per os diet in acute pediatric pancreatitis. In this minireview, we clearly show that early enteral nutrition, started within 24-48 h, is beneficial in acute pediatric pancreatitis. Prospective studies and better presentation of research are crucially needed to achieve a higher level of evidence.

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Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial

Cited by 20 publications

References 39 publications

Multiple Hits in Acute Pancreatitis: Components of Metabolic Syndrome Synergize Each Other’s Deteriorating Effects

Multiple Hits in Acute Pancreatitis: Components of Metabolic Syndrome Synergize Each Other’s Deteriorating Effects

Pancreatic Cancer: Multicenter Prospective Data Collection and Analysis by the Hungarian Pancreatic Study Group

Restoration of energy level in the early phase of acute pediatric pancreatitis

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