Journal Article

Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial

Besselink, Marc G., Lips, Daan J., Witteman, Ben J., Dijkgraaf, Marcel G., van Duijvendijk, Peter, Molenaar, I. Quintus, van Brunschot, Sandra, Schwartz, Matthijs P., Manusama, Eric R., van Dijk, Sven M., Boerma, Djamila, Schaapherder, Alexander F., Boermeester, Marja A., Spanier, B. W. Marcel, Straathof, Jan Willem, Bruno, Marco J., Haveman, Jan Willem, van der Hulst, René W., Bollen, Thomas L., Quispel, Rutger, van de Vrie, Wim, Schoon, Erik J., van Eijck, Casper H., Seerden, Tom C., van Goor, Harry, van der Peet, Donald L., Dejong, Cornelis H., Hadithi, Muhammed, van Lienden, Krijn P., Jansen, Jeroen M., van Grinsven, Janneke, Poen, Alexander C., Fockens, Paul, van Santvoort, Hjalmar C., Venneman, Niels G.

2019

Overview

Background Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention. 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / Analysis / Antibiotics / Ascites / Biomedicine / Care and treatment / Catheterization - adverse effects / Catheterization - mortality / Catheters / Clinical trials / Complication / Drainage / Drainage - adverse effects / Drainage - methods / Drainage - mortality / Endoscopy / Enteral nutrition / Equivalence Trials as Topic / Health Sciences / Hospitals / Humans / Infection / Infections / Intervention / Laparotomy / Length of Stay / Leukocytes / Medical care quality / Medical research / Medicine / Medicine & Public Health / Mortality / Multicenter Studies as Topic / Necrosis / Necrotizing pancreatitis / Netherlands / Pancreatitis / Pancreatitis, Acute Necrotizing - diagnosis / Pancreatitis, Acute Necrotizing - microbiology / Pancreatitis, Acute Necrotizing - mortality / Pancreatitis, Acute Necrotizing - therapy / Patient safety / Quality-Adjusted Life Years / Risk Factors / Sepsis / Statistics for Life Sciences / Step-up approach / Study Protocol / Time Factors / Time-to-Treatment / Timing / Treatment Outcome