ExTENSION. Long-term outcomes of a step-up endoscopic versus a surgical step-up approach in patients with infected pancreatic necrosis.

The ExTENSION studies the long-term clinical outcomes in patients after severe acute necrotizing pancreatitis. This long-term follow-up study is performed 5-9 years after patients enrolled in the TENSION trial. Patients underwent a surgical or endoscopic minimally invasive step-up approach to treat the infected (peri)pancreatic necrosis. The TENSION trial showed no difference in primary endpoints composite of death and major complications between groups. However, length of hospital stay was shorter and costs were lower in the endoscopy group. Therefore, current guidelines advise if feasible, to drain the necrotic collection endoscopically and if needed, to be followed by endoscopic necrosectomy. The surgical step-up approach consisted of percutaneous drainage and if needed, followed by VARD (video assisted retroperitoneal debridement). Out of the 98 patients, 15 patients died, leaving 83 eligible for follow-up. In this follow-up study we will research the long-term outcomes of the same endpoints as in the initial study.

A minimally invasive endoscopic step-up approach remains preferable over the surgical step-up approach to treat infected (peri)pancreatic necrosis. In the long term we expect no differences in the primary endpoint composite of death and major complications. The costs are expected to be lower in the endoscopy group.

At least 5 years after randomization. The follow-up up ends after the visit.

Collection of stool samples, sample of blood is drawn and quality of life questionnaires will be obtained.