PANTER
Trial question
What is the role of minimally invasive step-up approach to treatment in patients with necrotizing pancreatitis and infected necrotic tissue?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 88
88 patients (24 female, 64 male).
Inclusion criteria: patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue.
Key exclusion criteria: flare-up of chronic pancreatitis, previous exploratory laparotomy during the current episode of pancreatitis, previous drainage or surgery for confirmed or suspected infected necrosis, pancreatitis caused by abdominal surgery, and an acute intraabdominal event.
Interventions
N=43 a step-up approach to management of pancreatic necrosis (starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement).
N=45 primary open necrosectomy (maximal necrosectomy by laparotomy).
Primary outcome
Death or major complications
40%
69%
69.0 %
51.8 %
34.5 %
17.3 %
0.0 %
A step-up approach to management of pancreatic
necrosis
Primary open
necrosectomy
Significant
decrease ▼
NNT = 3
Significant decrease in death or major complications (40% vs. 69%; RR 0.57, 95% CI 0.38 to 0.87).
Secondary outcomes
Significant increase in new-onset multiple-organ failure or systemic complications (12% vs. 42%; RR 28, 95% CI 0.11 to 0.67).
No significant difference in death (19% vs. 16%; RR 1.2, 95% CI 0.48 to 3.01).
Conclusion
In patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue, a step-up approach to management of pancreatic necrosis was superior to primary open necrosectomy with respect to death or major complications.
Reference
van Santvoort HC, Besselink MG, Bakker OJ et al. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502.
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