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Biodegradable Stents in Primary Sclerosing Cholangitis

RecruitingNAAges 18 Years - anyAllKing's College Hospital NHS Trust
NCT07607353 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * PSC patients with a high grade stricture Exclusion Criteria: * 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 * Biliary cirrhosis with Child Pugh score \> 8 * Estimated transplant free survival \< 2 years as calculated by Mayo score \> 2 * Suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of metastasis, MRCP with mass lesion with contrast enhancenment, or rise in CA19.9 of \> 63 U/ml in the previous 4 months together with an absolute value \> 130 U/ml * Signs of current malignancy other than basal cell carcinoma * Life expectancy \< 24 months * Women pregnant at the time of screening * HIV or acute or chronic hepatitis B or hepatitis C or substance (drug or alcohol) misure within the previous 2 years.
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What it tests

  • archimedes stent
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Where

1 site
King's College Hospital, London
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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