Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial.
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van Grinsven Janneke, van Dijk Sven M, Dijkgraaf Marcel G, Boermeester Marja A, Bollen Thomas L, Bruno Marco J, van Brunschot Sandra, Dejong Cornelis H, van Eijck Casper H, van Lienden Krijn P, Boerma Djamila, van Duijvendijk Peter, Hadithi Muhammed, Haveman Jan Willem, van der Hulst René W, Jansen Jeroen M, Lips Daan J, Manusama Eric R, Molenaar I Quintus, van der Peet Donald L, Poen Alexander C, Quispel Rutger, Schaapherder Alexander F, Schoon Erik J, Schwartz Matthijs P, Seerden Tom C, Spanier B W Marcel, Straathof Jan Willem, Venneman Niels G, van de Vrie Wim, Witteman Ben J, van Goor Harry, Fockens Paul, van Santvoort Hjalmar C, Besselink Marc G, Dutch Pancreatitis Study Group
Аннотация
METHODS: POINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization.
DISCUSSION: The POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis.
TRIAL REGISTRATION: ISRCTN, 33682933 . Registered on 6 August 2015. Retrospectively registered.