Superiority of Step-up Approach vs Open Necrosectomy in Long-term Follow-up of Patients With Necrotizing Pancreatitis

Abstract Background and aims In a 2010 randomized trial (the PANTER trial), a surgical step-up approach for infected necrotizing pancreatitis was found to reduce the composite endpoint of death or major complications compared with open necrosectomy; 35% of patients were successfully treated with simple catheter drainage only. There is concern, however, that minimally invasive treatment increases the need for reinterventions for residual peripancreatic necrotic collections and other complications during the long term. We therefore performed a long-term follow-up study. Methods We re-evaluated all the 73 patients (of the 88 patients randomly assigned to groups) who were still alive after the index admission, at a mean 86 months (±11 months) follow up. We collected data on all clinical and health care resource utilization endpoints through this follow-up period. The primary endpoint was death or major complications (the same as for the PANTER trial). We also measured exocrine insufficiency, quality of life (using the SF-36 and EQ-5D forms) and Izbicki pain scores. Results From index admission to long-term follow up, 19 patients (44%) died or had major complications in the step-up group compared with 33 patients (73%) in the open-necrosectomy group ( P =.005). Significantly lower proportions of patients in the step-up group had incisional hernias (23% vs 53%; P =.004), pancreatic exocrine insufficiency (29% vs 56%; P =.03), or endocrine insufficiency (40% vs 64%; P =.05). There were no significant differences between groups in proportions of patients requiring additional drainage procedures (11% vs 13%; P =.99) or pancreatic surgery (11% vs 5%; P =.43), or in recurrent acute pancreatitis, chronic pancreatitis, Izbicki pain-scores, or medical costs. Quality of life increased during follow up without a significant difference between groups. Conclusions In an analysis of long-term outcomes of trial participants, we found the step-up approach for necrotizing pancreatitis to be superior to open necrosectomy, without increased risk of reinterventions.