Multicenter randomized trial comparing short-term stenting versus balloon dilatation for dominant strictures in primary sclerosing cholangitis

Titel: Multicenter randomized trial comparing short-term stenting versus
balloon dilatation for dominant strictures in primary sclerosing cholangitis.

Primary sclerosing cholangitis is a chronic progressive inflammatory disease of
the biliary tree leading to liver cirrhosis. During it's course, dominant bile
duct strictures occur in approximately 50% of patients. These can be
accompanied by worsening of cholestatic symptoms and jaudice and are an
indication for endoscopic treatment. The best form of treatment, either balloon
dilatation or short-term stent placement, has never been formally investigated.

The primary objective of the study is to compare the efficacy of single session
balloon dilatation with short-term stent placement in PSC patients with a
worsening of their cholestatic complaints.

This is a multicenter, open-label, randomized, intervention study with a
medical device.

During ERCP half of the subjects will receive a stent to treat the dominant
stricture and the other half will have the stricture strechted out with a
dilating balloon.

Currently both interventions belong to standard patient care armamentarium. The
burden for the patient consists of slightly more visits during the two year
follow-up (every 3 months instead of every 4-6 months) in addition to which
blood will be collected more often. During these visits the patient will also
be asked to fill in a quality of life questionnaire and a PSC symptom
questionnaire.
ERCP is associated with a low mortality (<0.5%) and acceptable morbidity (5%).
Most dreaded complications are severe post-ERCP pancreatitis (<2%) and
suppurative cholangitis (<2%). From the available retrospective literature data
the incidence of these complications does not seem to differ between the two
treatment modalities.