Biodegradable Stents in Primary Sclerosing Cholangitis
Recruiting now · Not applicable
Conditions studied: Primary Sclerosing Cholangitis (PSC)
In brief
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.
Key facts
- Study ID
- NCT07607353
- Run by
- King's College Hospital NHS Trust
- People needed
- 20
- Starts
- 2026-03-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- PSC patients with a high grade stricture
You may not qualify if…
- 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.
Where it is running
- King's College Hospital, London — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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