Biodegradable stents for high-grade bile duct strictures in PSC
Official title: Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
Run by King's College Hospital NHS Trust · NCT07607353 · Data updated 2026-11-12
This study tests whether placing biodegradable stents helps open tight bile duct strictures in people with primary sclerosing cholangitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07607353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with PSC and a high-grade biliary stricture suitable for ERCP who have not had recent stenting or balloon dilation and do not meet several exclusion criteria.
✕Probably not a fit
Patients with more advanced liver disease, active infection, malignancy, or other contraindications may not benefit from stenting or could incur risks without improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and technical success of Archimedes biodegradable stents placed during endoscopic retrograde cholangiopancreatography (ERCP) for high-grade biliary strictures in PSC patients. The trial compares stenting to balloon dilation alone by looking at recurrence-free rates at 12 months and changes in symptoms, liver tests, and quality of life. Secondary outcomes include overall clinical success, adverse events, and liver-related morbidity over a year. Eligible participants have PSC with a high-grade stricture and meet specific exclusion criteria to minimize risk. The study is led by King’s College Hospital NHS Trust in London with no listed collaborators at other sites.
Why it matters
Potential benefit: If successful, patients may experience fewer procedures and better long-term relief of bile duct obstruction.
How similar studies have gone: Previous short-term data suggested stents might not reduce recurrence and could increase serious adverse events, so this study probes long-term outcomes with biodegradable stents.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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King's College Hospital, London
London, United Kingdom Recruiting
Study contacts
- Principal investigator: DEEPAK JOSHI, PhD — King's College Hospital NHS Trust
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.