Dataset Information

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

ABSTRACT:

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.

SUBMITTER: van Grinsven J

PROVIDER: S-EPMC6482524 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

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

van Grinsven Janneke J van Dijk Sven M SM Dijkgraaf Marcel G MG Boermeester Marja A MA Bollen Thomas L TL Bruno Marco J MJ van Brunschot Sandra S Dejong Cornelis H CH van Eijck Casper H CH van Lienden Krijn P KP Boerma Djamila D van Duijvendijk Peter P Hadithi Muhammed M Haveman Jan Willem JW van der Hulst René W RW Jansen Jeroen M JM Lips Daan J DJ Manusama Eric R ER Molenaar I Quintus IQ van der Peet Donald L DL Poen Alexander C AC Quispel Rutger R Schaapherder Alexander F AF Schoon Erik J EJ Schwartz Matthijs P MP Seerden Tom C TC Spanier B W Marcel BWM Straathof Jan Willem JW Venneman Niels G NG van de Vrie Wim W Witteman Ben J BJ van Goor Harry H Fockens Paul P van Santvoort Hjalmar C HC Besselink Marc G MG

Trials 20190425 1

<h4>Background</h4>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 ...[more]

PMID: 31023380

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Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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