AXIOMA: Hot AXios metal stent for Infected walled-off pancreatic necrOsis Management

Infected (peri)pancreatic necrosis is a life-threatening complication of acute pancreatitis. Current guidelines recommend a step-up approach in these patients, starting with catheter drainage, and if necessary, followed by a minimal invasive necrosectomy. Recent literature demonstrated no difference in mortality and major morbidity between the endoscopic and surgical step-up approach for infected necrotizing pancreatitis. However, the endoscopic step-up approach resulted in shorter hospital stay and less pancreatic fistulas. These findings suggest that the endoscopic step-up approach should be the preferred treatment modality in patients with infected necrotizing pancreatitis. The use of lumen-apposing metal stents (LAMS), like the Hot-AXIOS stent, might optimize endoscopic drainage even more and reduce the need for additional endoscopic transluminal necrosectomy and its associated morbidity and costs.

This will be investigated in the AXIOMA study, a prospective multicenter study performed in the centers of the nationwide Dutch Pancreatitis Study Group. This cohort of patients will be compared to the 51 endoscopically treated patients of the Dutch TENSION trial.

The use of LAMS (lumen-apposing fully covered self-expanding metal stents) will optimize endoscopic drainage in patients with infected necrotizing pancreatitis, and therefore reduce the need for additional endoscopic necrosectomy and its associated morbidity and costs.

1. 6 weeks: MRI/MRCP (before 2.)

2. 6 weeks: Hot AXIOS-stent removal

3. Follow-up 3 months: exocrine and endocrine pancreatic function, questionnaires (SF-36, EQ-5D, SF-HLQ)

4. Follow-up 6 months: MRI/MRCP, exocrine and endocrine pancreatic function, questionnaires (SF-36, EQ-5D, SF-HLQ)

Endoscopic transluminal drainage with the Hot AXIOS stent