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001-es BibID:	BIBFORM083103
Első szerző:	Koncz Balázs
Cím:	LIFEStyle, Prevention and Risk of Acute PaNcreatitis (LIFESPAN) : protocol of a multicentre and multinational observational case-control study / Koncz Balázs, Darvasi Erika, Erdősi Dalma, Szentesi Andrea, Márta Katalin, Erőss Bálint, Pécsi Dániel, Gyöngyi Zoltán, Girán János, Farkas Nelli, Papp Maria, Fehér Eszter, Vitális Zsuzsanna, Janka Tamás, Vincze Áron, Izbéki Ferenc, Dunás-Varga Veronika, Gajdán László, Török Imola, Károly Sándor, Antal Judit, Zádori Noémi, Lerch Markus M., Neoptolemos John, Sahin-Toth Miklos, Petersen Ole H., Hegyi Péter
Dátum:	2020
ISSN:	2044-6055 2044-6055
Megjegyzések:	AbstrACt Introduction Acute pancreatitis (AP) is a life- threatening inflammatory disease of the exocrine pancreas which needs acute hospitalisation. Despite its importance, we have significant lack of knowledge whether the lifestyle factors elevate or decrease the risk of AP or influence the disease outcome. So far, no synthetising study has been carried out examining associations between socioeconomic factors, dietary habits, physical activity, chronic stress, sleep quality and AP. Accordingly, LIFESPAN identifies risk factors of acute pancreatitis and helps to prepare preventive recommendations for lifestyle elements. Methods and analysis LIFESPAN is an observational, multicentre international case?control study. Participating subjects will create case and control groups. The study protocol was designed according to the SPIRIT guideline. Patients in the case group (n=1700) have suffered from AP (alcohol- induced, n=500; biliary, n=500; hypertriglyceridemiainduced, n=200; other, n=500); the control group subjects have no AP in their medical history. Our study will have three major control groups (n=2200): hospital- based (n=500), population- based (n=500) and aetiology- based (alcohol, n=500; biliary, n=500 and hypertriglyceridemia, n=200). All of them will be matched to the case group individually by gender, age and location of residence. Aggregately, 3900 subjects will be enrolled into the study. The study participants will complete a complex questionnaire with the help of a clinical research administrator/study nurse. Analysis methods include analysis of the continuous and categorical values. Ethics and dissemination The study has obtained the relevant ethical approval (54175-2/2018/EKU) and also internationally registered (ISRCTN25940508). After obtaining the final conclusions, we will publish the data to the medical community and will also disseminate our results via open access. trial registration number ISRCTN25940508; Pre- results.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban acute pancreatitis lifestyle prevention
Megjelenés:	BMJ Open. - 10 : 1 (2020), p. 1-9. -
További szerzők:	Darvasi Erika Erdősi Dalma Szentesi Andrea Márta Katalin Erőss Bálint Pécsi Dániel Gyöngyi Zoltán Girán János Farkas Nelli Papp Mária (1975-) (belgyógyász, gasztroenterológus) Fehér Eszter Vitális Zsuzsanna (1963-) (belgyógyász, gasztroenterológus) Janka Tamás Vincze Áron Izbéki Ferenc Dunás-Varga Veronika Gajdán László Török Imola Károly Sándor Antal Judit Zádori Noémi Lerch, Markus M. Neoptoleomos, Johan P. Sahin-Tóth Miklós Petersen, Ole H. Hegyi Péter Jenő (belgyógyász)
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001-es BibID:	BIBFORM078558
035-os BibID:	(cikkazonosító)e025551 (PMID)31289058 (PMCID)PMC6629406
Első szerző:	Kucserik Levente Pál
Cím:	Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study) : protocol of a multicenter randomized clinical trial / Levente Pál Kucserik, Katalin Márta, Áron Vincze, György Lázár, László Czakó, Zsolt Szentkereszty, Mária Papp, Károly Palatka, Ferenc Izbéki, Áron Altorjay, Imola Török, Sorin Barbu, Marcel Tantau, András Vereczkei, Lajos Bogár, Márton Dénes, Imola Németh, Andrea Szentesi, Noémi Zádori, Judit Antal, Markus M. Lerch, John Neoptolemos, Miklós Sahin-Tóth, Ole H. Petersen, Dezső Kelemen, Péter Hegyi
Dátum:	2019
ISSN:	2044-6055
Megjegyzések:	Introduction. According to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomized, controlled multicenter trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. We hypothesize that carrying out a sphincterotomy (ES) allows us to delay cholecystectomy, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure. Methods/Design. EMILY is a prospective, randomized, controlled multicenter trial. All patients with mild ABP, who underwent ES during the index admission, or in the medical history will be informed to take part in EMILY study. The patients will be randomized into two groups: (1) early cholecystectomy (within 6 days after discharge) and (2) patients with delayed (interval) cholecystectomy (between 45 and 60 days after discharge). During a 12-month period, 93 patients will be enrolled from participating clinics. The primary endpoint is a composite endpoint of mortality and recurrent acute biliary events (that is, recurrent ABP, acute cholecystitis, uncomplicated biliary colic, and cholangitis). The secondary endpoints are organ failure, biliary leakage, technical difficulty of the cholecystectomy, surgical and other complications. Ethics and dissemination. The trial has been registered at the ISRCTN (ref no. 10667869) and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176-5).
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk acute biliary pancreatitis cholecystectomy endoscopic sphincterotomy
Megjelenés:	BMJ Open. - 9 : 7 (2019), p. 1-8. -
További szerzők:	Márta Katalin Vincze Áron Lázár György Czakó László Szentkereszty Zsolt (1961-) (sebész) Papp Mária (1975-) (belgyógyász, gasztroenterológus) Palatka Károly (1961-) (belgyógyász, gasztroenterológus) Izbéki Ferenc Altorjay Áron Török Imola Barbu, Sorin Tantau, Marcel Vereczkei András Bogár Lajos Dénes Márton Németh Imola Szentesi Andrea Zádori Noémi Antal Judit Lerch, Markus M. Neoptoleomos, Johan P. Sahin-Tóth Miklós Petersen, Ole H. Kelemen Dezső Hegyi Péter Jenő (belgyógyász)
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001-es BibID:	BIBFORM082674
Első szerző:	Zádori Noémi
Cím:	EarLy elimination of fatty acids iN hypertriglyceridemia-induced acuTe pancreatitis (ELEFANT trial) : protocol of an open-label, multicenter, adaptive randomized clinical trial / Noémi Zádori, Noémi Gede, Judit Antal, Andrea Szentesi, Hussain Alizadeh, Áron Vincze, Ferenc Izbéki, Mária Papp, László Czakó, Márta Varga, Enrique de-Madaria, Ole H. Petersen, Vijay P. Singh, Julia Mayerle, Nándor Faluhelyi, Attila Miseta, István Reiber, Péter Hegyi
Dátum:	2020
ISSN:	1424-3903
Megjegyzések:	Introduction: Acute pancreatitis (AP) is a life-threatening inflammatory disease, with no specific pharmacologi- cal treatment. However, concerning some etiologies, early specific intervention (such as ERCP in biliary AP) has proven to be remarkably beneficial. Hypertriglyceridemia (HTG) induces severe pancreatic damage by several direct (cellular damage) and indirect (deterioration of microcirculation) mechanisms. Published data suggest that early removal of triglycerides (TGs) and toxic free fatty acids (FFAs) may be advantageous; however, high-quality evidence is still missing in the literature. Methods: /Design: ELEFANT is a randomized controlled, multicenter, international trial testing the concept that early elimination of TGs and FFAs from the blood is beneficial in HTG-AP. The study will be performed with the adaptive "drop-the-loser" design, which supports the possibility of dropping the inferior treatment arm, based on the results of the interim analysis. Patients with HTG-AP defined by TG level over 11.3 mmol/l (1000 mg/dL) are randomized into three groups: (A) patients who undergo plasmapheresis and receive aggressive fluid resuscita- tion; (B) patients who receive insulin and heparin treatment with aggressive fluid resuscitation; and (C) patients with aggressive fluid resuscitation. Please note that all intervention must be started within 48 h from the onset of abdominal pain. Exclusion criteria are designed logically to decrease the possibility of any distorting effects of other diseases. The composite primary endpoint will include both severity and mortality.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Acute pancreatitis Hypertriglyceridemia Plasmapheresis Free fatty acids Heparin Insulin Randomized clinical trial
Megjelenés:	Pancreatology. - 20 : 3 (2020), p. 369-376. -
További szerzők:	Gede Noémi Antal Judit Szentesi Andrea Alizadeh, Hussain Vincze Áron Izbéki Ferenc Papp Mária (1975-) (belgyógyász, gasztroenterológus) Czakó László Varga Márta de-Madaria, Enrique Petersen, Ole H. Singh, Vijay P. Mayerle, Julia Faluhelyi Nándor Miseta Attila Reiber István Hegyi Péter (pszichológus)
Pályázati támogatás:	GINOP-2.3.2-15-2016-00048 GINOP KH-125678 Egyéb EFOP-3.6.2-16-2017-00006 EFOP LP2014-10/2014 Egyéb
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