Biodegradable Stents in Primary Sclerosing Cholangitis
Not applicable · Testing archimedes stent · 1 site · King's College Hospital NHS Trust
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing archimedes stent (a device) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis (PSC).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- PSC patients with a high grade stricture
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-03-01.
- Main results expected around 2027-04-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Groups in this study
- Archimedes stent insertion (listed as: experimental group)
Main thing being measured
- Deployment of biodegradable stent placement across stricture at ERC in 20 patients (at time of primary ERC)
In the researchers’ words
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…
Words you might see
- MRCP: an MRI scan of the bile ducts and pancreas.
- UDCA (ursodiol): a bile acid medicine that some people with PSC take.
- Cirrhosis: advanced scarring of the liver.
- Cholangiocarcinoma: cancer of the bile ducts.
- Cholestasis: reduced or blocked flow of bile.
- Randomized: participants are put into groups by chance, like a coin flip.
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis (PSC) |
| Lead sponsor | King's College Hospital NHS Trust |
| Enrollment | 20 (estimated) |
| Start date | 2026-03-01 |
| Primary completion (est.) | 2027-04-01 |
| First posted | 2026-05-26 |
| Last updated | 2026-05-29 |
| Official title | Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC |
| ClinicalTrials.gov ID | NCT07607353 |
Interventions
- archimedes stent (Device)
archimedes stent for HGS
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital, London | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.