ExTENSION: Long-Term Follow-up Study of an Endoscopic versus a Surgical Step-up Approach for Infected Necrotizing Pancreatitis

Abstract

Introduction: In 2018, the TENSION trial found that the endoscopic step-up approach is preferred over the surgical approach for necrotizing pancreatitis, because of fewer pancreaticocutaneous fistulas and shorter hospital stay. However, it remains unclear whether long-term outcomes (> 6 months) differ between both approaches. Method: TENSION trial participants were prospectively re-evaluated after a follow-up period of at least 5 years. The composite primary endpoint, similar to the TENSION trial, consisted of mortality and major complications occurring between randomization and the end of long-term follow-up. Results: The mean follow-up period was 7 years (84 ± 11 months). The primary endpoint occurred in 27 patients (53%) in the endoscopy group and 27 patients (57%) in the surgery group (RR 0.93, 95% CI 0.65 to 1.32, P=0.69). Mortality did not differ (15 patients (29%) vs. 7 (15%); RR 1.89, 95% CI 0.89 to 4.42). The endoscopy group had fewer pancreaticocutaneous fistulas (8% vs. 34%; RR 0.23, 95% CI 0.08–0.83) and fewer drainages during long-term follow-up (7% vs. 24%; RR 0.29, 95% CI 0.09 - 0.99). No differences were found in exocrine insufficiency (57% vs. 66%, RR 0.86, 95% CI 0.63 - 1.18) or endocrine insufficiency (31% vs. 34%, RR 0.92, 95% CI 0.52 - 1.63). QoL scores did not differ between group at long-term follow-up. Conclusion: In this long-term follow-up study, we found the endoscopic step-up approach to result in fewer pancreaticocutaneous fistulas and reinterventions. No differences were found in mortality, major complications and quality of life at the end of long-term follow-up.