title: Preventive pancreatic stents in the management of acute biliary pancreatitis (PREPAST trial): pre-study protocol for a multicenter, prospective, randomized, interventional, controlled trial.
abstract: BACKGROUND
  The outcome of the most common biliary form of acute pancreatitis has not changed even with the better described indications for early endoscopic intervention. It may be due to the fact that this intrevention theoretically can cause further pancreatic injury or cannot always relieve the pancreatic duct obstruction. We hypothesize that maintaining the outflow of the pancreatic duct with preventive pancreatic stents at the early ERCP improves the outcome of acute biliary pancreatitis.
  
  
  METHODS
  PREPAST is a prospective, randomized, controlled, multicenter trial. Patients with acute biliary pancreatitis with coexisting cholangitis are randomized to undergo urgent endoscopic intervention with or without pancreatic stenting within 48 h from the onset of pain, and in addition patients without signs of cholangitis but cholestasis are randomly allocated to recieve conservative treatment or early endoscopic intervention with or without pancreatic stenting within 48 h from the onset of pain. Patients without acute cholangitis and signs of cholestasis recieve conservative treatment. 230 patients are planned to be enrolled during a 48 months period from different centers. The primary endpoint is the outcome of acute biliary pancreatitis as described by the latest guidelines. Secondary endpoints include mortality data, and other variables not analyzed as a primary endpoint but related to the pancreatitis or the pancreatic stenting.
  
  
  CONCLUSIONS
  The PREPAST trial is designed to show whether early endoscopic intervention with the usage of preventive pancreatic stenting improves the outcome of acute biliary pancreatitis. The study has been registered at the International Standard Randomised Controlled Trial Number (ISRCTN) Register (trial ID: ISRCTN13517695).
authors.affiliation: Department of Gastroenterology and Endoscopy, Bács-Kiskun County Hospital, Nyíri út 38, 6000 Kecskemét, Hungary. Electronic address: dubravcsikzs@gmail.com.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Dubravcsik
authors.affiliation: 2nd Department of Internal Medicine, Semmelweis University, Szentkirályi u. 46, 1088 Budapest, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Madácsy
authors.affiliation: Department of Gastroenterology, State Health Centre, Podmaniczky u. 111, 1062 Budapest, Hungary.
authors.forename: Tibor
authors.initials: T
authors.lastname: Gyökeres
authors.affiliation: 1st Department of Internal Medicine, University of Pécs, Rákóczi út 2, 7622 Pécs, Hungary.
authors.forename: Áron
authors.initials: Á
authors.lastname: Vincze
authors.affiliation: 1st Department of Internal Medicine, University of Szeged, Korányi fasor 8-10, 6720 Szeged, Hungary.
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Szepes
authors.affiliation: 1st Department of Internal Medicine, University of Szeged, Korányi fasor 8-10, 6720 Szeged, Hungary; MTA-SZTE Lendület Translational Gastroenterology Research Group, Korányi fasor 8-10, 6720 Szeged, Hungary.
authors.forename: Péter
authors.initials: P
authors.lastname: Hegyi
authors.affiliation: Department of Gastroenterology and Endoscopy, Bács-Kiskun County Hospital, Nyíri út 38, 6000 Kecskemét, Hungary; 1st Department of Internal Medicine, University of Szeged, Korányi fasor 8-10, 6720 Szeged, Hungary.
authors.forename: István
authors.initials: I
authors.lastname: Hritz
authors.affiliation: Department of Gastroenterology and Endoscopy, Bács-Kiskun County Hospital, Nyíri út 38, 6000 Kecskemét, Hungary.
authors.forename: Attila
authors.initials: A
authors.lastname: Szepes
mesh_terms: D000368:Aged; D001660:Biliary Tract Diseases / Q000517:prevention & control / Q000601:surgery*; D001662:Biliary Tract Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000601:surgery; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000517:prevention & control / Q000601:surgery*; D011379:Prognosis; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D016717:Sphincterotomy, Endoscopic; D015607:Stents / Q000009:adverse effects
keywords: Acute pancreatitis; Biliary pancreatitis; Complication; Endoscopic retrograde cholangiopancreatography; Outcome; Pancreatic stent