New biodegradable stents offer hope for PSC patients
NCT ID NCT07607353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether biodegradable stents can safely open narrowed bile ducts in 20 people with primary sclerosing cholangitis (PSC). The stents are placed during an endoscopic procedure and dissolve over time, aiming to improve symptoms like itching and fatigue and prevent the stricture from coming back within a year. Participants must have a high-grade stricture and no recent stent or balloon treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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King's College Hospital, London
RECRUITINGLondon, SE5 9RS, United Kingdom
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