AXIOMA: Hot AXIOS metal stent for infected walled-off pancreatic necrosis management.

Infected necrotizing pancreatitis complicates 10% of all acute pancreatitis
episodes and is associated with a 20% mortality. Currently, the *step-up
approach* is the treatment of choice, consisting of catheter drainage and, if
necessary, followed by a minimally invasive necrosectomy.This can either be
performed via a percutaneous or endoscopic approach. The latter is less
invasive and associated with less pancreatic fistula and shorter hospital stay.
An increasing number of studies suggest that optimal drainage is the
cornerstone of the treatment of infected pancreatic necrosis. By optimizing
endoscopic transluminal drainage necrosectomy can be prevented or limited. The
use of the Hot AXIOS-stent might optimize endoscopic drainage and therefore
reduce the need for additional endoscopic necrosectomy and its associated
morbidity and costs.

Investigate whether the use of the Hot AXIOS lumen apposing metal stent is
superior to standard plastic pigtails stents for drainage of infected
pancreatic necrosis.

Prospective multicenter study in centers of the nationwide Dutch Pancreatitis
Study Group. Patients who fulfill the inclusion criteria and give written
informed consent for participating in the study receive the investigational
treatment of endoscopic transluminal drainage with the Hot AXIOS metal stent.
This cohort of patients will be compared with the 58 endoscopically treated
patients of the TENSION and the PENGUIN trial. These patients received
endoscopic transluminal drainage with plastic pigtails stents.

Endoscopic transluminale drainage with the Hot AXIOS stent.

By optimizing endoscopic transluminal drainage, the need for additional
endoscopic necrosectomy might be prevented or limited. Optimal endoscopic
drainage might prevent further deterioration of these patients and therefore
leads to less complications, lowers hospital stay and medical costs. The Hot
AXIOS stent was developed within the same framework of previous stents with the
aim of gaining improvement in patient outcomes. Therefore, the stent might
present an incremental innovation with respect to previous stents. Literature
reports that the use to of LAMS is safe and effective. However, some adverse
events, for instance major bleeding, have been described as well. Recent
literature shows that the use of metal stents is associated with lower
bleeding, a trend toward lower perforation and stent occlusion, although with
higher migration, which may result in an additional procedure to replace the
stent.