Extension: Long-term Follow-up Study of an Endoscopic versus Surgical Step-up Approach for Infected Necrotizing Pancreatitis

Abstract

Introduction: The TENSION trial (published in 2018) found that the endoscopic step-up approach in patients with infected necrotizing pancreatitis does not reduce mortality or major complications. However, it prevents pancreatic fistulas and shortens hospital stay, as compared to the surgical step-up approach. Nonetheless, the question remains whether long-term outcomes (>6 months) differ between both approaches. The aim of this study is to compare long-term clinical outcomes after the endoscopic and surgical step-up approach. Methods: TENSION trial participants were prospectively evaluated by interviews and pancreatic function measurements after a follow-up period of at least 5 years. Endpoints were similar to those of the original TENSION trial. The primary endpoint was composed of death and major complications, occurring between randomization and end of long-term follow-up. Secondary endpoints included the individual components of the primary endpoint, pancreatic fistula, exocrine and endocrine insufficiency, total hospital stay, reinterventions, and quality of life (QoL). Results: The mean follow-up period was 7 years (84±11 months). The primary endpoint occurred in 29 patients (57%) from the endoscopy group and in 27 patients (57%) from the surgery group (RR 0.99, 95% CI 0.70–1.40). No difference was found in overall mortality (15 patients (29%) vs. 7 (15%) respectively; RR 1.89, 95% CI 0.89–4.42). During long-term follow-up, the first patient died 2.5 years after randomization, and all but one deaths were not related to pancreatitis (5 out of 6 (83%) vs. 1 (100%); RR 0.83, 95% CI 0.58–1.19). In the endoscopy group, fewer pancreatic fistulas (8% vs. 36%; RR 0.25, 95% CI 0.09–0.69) and additional drainages were observed during follow-up (7% vs. 24%; RR 0.29, 95% CI 0.09–0.99). The endoscopy group reported higher physical health scores (SF-36) at 3 months after randomization (42±11 vs. 36±10, P=0.04), however, long-term QoL scores did not differ (EQ-5D 0.80±0.23 vs. 0.86±0.17, P=0.24). Conclusion: During the long-term follow-up of TENSION trial participants, we found no differences in mortality and major complications between the endoscopic and surgical step-up approach for infected necrotizing pancreatitis. However, the endoscopic step-up approach results in fewer pancreatic fistulas, additional drainage procedures, and a faster physical recovery. These results confirm that, if both techniques are feasible, the endoscopic approach should be preferred.