Research in context
Evidence before this study
Before the start of our trial, we did an extensive literature search using PubMed, Embase, and the Cochrane Library database for studies published between Jan 1, 1980, and Dec 31, 2010. We used the search terms “necrosectomy” and “pancreatitis”. We included only studies with patients with infected necrosis or symptomatic sterile necrosis, published in English. Studies needed to report the results of patients with infected necrosis separately, as well as mortality and complications. We excluded cohorts with fewer than five patients and studies of patients with chronic pancreatitis. We identified one small pilot trial, 13 cohort studies, and two systematic reviews. The pilot trial of 20 patients compared an endoscopic necrosectomy with a surgical necrosectomy in patients with infected necrosis. This trial was not designed or powered for differences in clinically relevant outcomes but the results suggested a reduced pro-inflammatory response and development of new-onset organ failure after endoscopic necrosectomy. Furthermore, this pilot trial did not incorporate the step-up approaches because it only included patients in whom catheter drainage had failed and subsequently required necrosectomy. The other studies had numerous limitations (ie, small number of patients, retrospective study design, no fixed treatment algorithms, and included patients with sterile necrosis) but they all showed promising results in favour of endoscopic necrosectomy by indirect comparison with surgical necrosectomy. The pilot trial showed significant results by direct comparison.
Added value of this study
To our knowledge, our study is the first high-quality trial to compare an endoscopic step-up approach with the current reference standard of a surgical step-up approach in patients with infected necrosis. Our results are the first to provide level 1 evidence for a reduction in hospital stay and pancreatic fistulas in favour of the endoscopic step-up approach.
Implications of all the available evidence
On the basis of the results of this study, we expect that guidelines will shift from minimally invasive surgery towards endoscopic treatment. Furthermore, treatment of infected necrosis should always take a step-up approach, with endoscopic drainage as the first step. In conclusion, an endoscopic step-up approach reduces pancreatic fistula, length of hospital stay, and costs without any evidence for impaired safety; therefore, this approach should be considered the strategy of choice in patients with infected necrosis.