Biodegradable Stents in Primary Sclerosing Cholangitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust

About this trial

In patients with PSC, endoscopic therapy of strictures aims to improve cholestasis by relieving the biliary obstruction via endoscopic biliary dilatation with consideration of plastic stents in strictures refractory to dilatation due to the risk of pancreatitis and cholangitis . Short term stents have been shown to have similar recurrence-free rates compared to dilatation in a randomised control trial; however, this was terminated after interim analysis due to higher rates of serious adverse events in the stent group. The long term benefits are unclear; however, it may lead to improved survival compared to predicted survival. In this group of patients with limited treatment options, biodegradable stents may provide an attractive additional treatment modality in the management of high grade strictures.

Eligibility criteria

Qualifiers

PSC patients with a high grade stricture

Disqualifiers

Prior stenting or balloon dilatation within the previous 4 months

Signs of bacterial cholangitis as defined by definite cholangitis

Change of UDCA therapy within 4 weeks

Inability to give informed consent

Trial design

Treatments tested in this trial

  • archimedes stent

Treatment groups

20 Participants
are divided into 1 treatment group