Biodegradable self-expandable stents for pancreatic duct strictures due to chronic pancreatitis

A fibrotic pancreatic duct stricture is a common complication of chronic
pancreatitis and is typically difficult to treat. Conventional endoscopic
treatment consists of the sequential placement of an increasing number of
plastic stents for 6 to 12 months, with 3-monthly stent exchanges. In contrast
with post-operative biliary strictures, the success rate of endoscopic
treatment in this patient group is much lower, and more than half of the
patients will eventually undergo surgery.

Treatment with self-expandable stents seems more effective due to the larger
diameter of the stent, but the unremovable nature of these metal stents makes
them unsuitable for treatment of benign strictures. Therefore, biodegradable
self-expanding stents would be the perfect solution for this patient group. Not
only would more effective treatment prevent surgery, but also, therapy would be
more patient friendly, because it would involve less procedures.

The aim of this study is to investigate the safety and efficacy of
biodegradable self-expandable stents in patients with a benign fibrotic
pancreatic duct stricture due to chronic pancreatitis.

This study is a prospective clinical intervention trial, executed in two
different centers; the endoscopy department of the Erasmus University Medical
Center in Rotterdam, and the Division of Gastroenterology & Hepatology of the
University Hospital Leuven, Belgium

After stent placement, patients will be followed for a 1-year period,
clinically and with abdominal ultrasound, at 3 monthly intervals. In addition,
after 6 months, an ERCP will be performed to evaluate stent and stricture
resolution.

The intervention consists of the endoscopic placement of a biodegradable
self-expandable stent to cross the pancreatic duct stricture. This stent is
expected to degrade within 6 months.

The study does not cause any additional burden on patients, compared to
endoscopic treatment with plastic stents. The stent placement and follow-up
procedures are similar to standard clinical care. Participation will even
decrease the burden, because 3-monthly stent exchange procedures are not
necessary.

The risks associated with participation in the study are not expected to be any
different from the complications of regular treatment with plastic stents.
Patients might benefit from participation, because the chance of stricture
resolution is expected to be higher. Therefor, an operation might be
prevented.