Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial

• Published in: BMJ open Vol. 9; no. 7; p. e025551
• Main Authors: Kucserik, Levente Pál, Márta, Katalin, Vincze, Áron, Lázár, György, Czakó, László, Szentkereszty, Zsolt, Papp, Mária, Palatka, Károly, 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, Neoptolemos, John, Sahin-Tóth, Miklós, Petersen, Ole H, Kelemen, Dezső, Hegyi, Péter
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 09.07.2019; BMJ Publishing Group
• Subjects: Bile; Cholecystectomy; Clinical trials; Committees; Endoscopy; Ethics; Evidence-based medicine; Gallbladder diseases; Gallstones; Gastroenterology; Gastroenterology and Hepatology; Laparoscopy; Mortality; Pancreatitis; Pediatrics; Surgeons; Atlanta Georgia; United States > US; acute biliary pancreatitis; cholecystectomy; endoscopic sphincterotomy
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2018-025551

IntroductionAccording to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomised, controlled multicentre 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 hypothesise 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/DesignEMILY is a prospective, randomised, controlled multicentre 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 randomised 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 disseminationThe trial has been registered internationally ISRCTN 10667869, and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176–5).Trial registration number ISCRTN10667869; Pre-results.