Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION):long-term follow-up of a randomized trial

BACKGROUND & AIMS: Previous randomized trials, including the TENSION trial, demonstrated that the endoscopic step-up approach might be preferred over the surgical step-up approach in patients with infected necrotizing pancreatitis based on favorable short-term outcomes. We compared long-term clinical outcomes of both step-up approaches after a period of at least 5 years.METHODS: In this long-term follow-up study, we re-evaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-months follow-up. The primary endpoint, similar to the TENSION trial, was a composite of death and major complications. Secondary endpoints included individual major complications, pancreaticocutaneous fistula, re-interventions, pancreatic insufficiency, and quality of life.RESULTS: After a mean follow-up period of 7 years, the primary endpoint occurred in 27 patients (53%) in the endoscopy and in 27 patients (57%) in the surgery group (risk ratio [RR] 0.93, 95% confidence interval [CI] 0.65 to 1.32, P=0.688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs. 34%; RR 0.23, 95% CI 0.08 to 0.83). After the initial 6-months follow-up, the endoscopy group needed fewer re-interventions than the surgery group (7% vs. 24%; RR 0.29, 95% CI 0.09 to 0.99). Pancreatic insufficiency and quality of life did not differ between groups.CONCLUSIONS: At long-term follow-up, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing death or major complications in patients with infected necrotizing pancreatitis. However, patients assigned to the endoscopic approach developed overall fewer pancreaticocutaneous fistulas and needed fewer re-interventions after the initial 6-months follow-up. Netherlands Trial Register no: NL8571.