Primary Sclerosing Cholangitis (PSC)BSTPSCNCT07607353
Biodegradable Stents in Primary Sclerosing Cholangitis
A study testing archimedes stent in people with Primary Sclerosing Cholangitis (PSC), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- archimedes stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSC patients with a high grade stricture
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital, London
London, SE5 9RS
D Joshi, PhD, 02032999000, d.joshi@nhs.net
About this study
Official title: Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
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.
Read the detailed description
Research hypothesis
The use of biodegradable stents leads to remodelling of high grade strictures in patients with PSC with fewer interventions in comparison to balloon dilation alone with a comparable risk profile to current therapy.
Primary endpoint
Technical success and safety of biodegradable stent placement at ERC
Secondary endpoints
- Cumulative recurrence -free rate of primary high grade strictures within 12 months
- Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
- Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
- Improvement in quality fo life as assessed by the Short form-36 (SF-36).
- Mortality, morbidity, local complications, stricture recurrence, decompensation of liver disease, liver transplantation over 12 months.
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- archimedes stent
- Keywords
- PSC, ERCP, Biodegradable stents
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
archimedes stentDevice
archimedes stent for HGS
| Study group | Role | What they receive |
|---|---|---|
| Archimedes stent insertion | Experimental | Archimedes stent insertion at ERCP for patients with PSC and a HGS Receives: Device: archimedes stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
Deployment of stent across the stricture - yes or no
Measured: at time of primary ERC
Secondary outcomes (9)
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
has the stricture reoccured (yes or no) at 12 months post ERC and stent
Measured: through study completion up to 12 months
Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
change in pruritus, fatigue, pain and fever
Measured: Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
Change in liver blood tests:
- ALP, AST, ALT, Bilirubin
Measured: At week 2 and 12 weeks post ERCP
Change in quality fo life as assessed by the Short form-36 (SF-36
Change in QoL
Measured: after ERC and assesment at 2 weeks, 12 weeks and 12 months
Mortality over 12 months.
Death related to PSC
Measured: Within 12 months of primary ERCP
morbidity related to ERC
Complications including cholangitis and pancreatitis post ERC
Measured: within 12 months of ERC
stricture recurrence post ERC
Development of a stricture in the bile duct
Measured: 12 months post ERC
Development of ascites post erc
development of abdominal ascites post ERC
Measured: up to 12 months post ERC
Need for liver transplantation
patients who are assessed and then listed for liver transplant
Measured: up to 12 months following ERC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Mar 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEEPAK JOSHI, PhD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607353
- Sponsor's protocol ID
- IRAS 336318
- Acronym
- BSTPSC
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
- ClinicalTrials.gov ID
- NCT07607353
- Acronym / sponsor ID
- BSTPSC / IRAS 336318
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Keywords
- PSC, ERCP, Biodegradable stents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research hypothesis
The use of biodegradable stents leads to remodelling of high grade strictures in patients with PSC with fewer interventions in comparison to balloon dilation alone with a comparable risk profile to current therapy.
Primary endpoint
Technical success and safety of biodegradable stent placement at ERC
Secondary endpoints
- Cumulative recurrence -free rate of primary high grade strictures within 12 months
- Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
- Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
- Improvement in quality fo life as assessed by the Short form-36 (SF-36).
- Mortality, morbidity, local complications, stricture recurrence, decompensation of liver disease, liver transplantation over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Archimedes stent insertion | Experimental | Device: archimedes stentArchimedes stent insertion at ERCP for patients with PSC and a HGS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PSC patients with a high grade stricture
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| archimedes stentarchimedes stent for HGS | Device | Archimedes stent insertion |
Primary outcome
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
Time frame: at time of primary ERC
Deployment of stent across the stricture - yes or no
9 secondary outcomes
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
Time frame: through study completion up to 12 months
Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
Time frame: Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
Time frame: At week 2 and 12 weeks post ERCP
Change in quality fo life as assessed by the Short form-36 (SF-36
Time frame: after ERC and assesment at 2 weeks, 12 weeks and 12 months
Mortality over 12 months.
Time frame: Within 12 months of primary ERCP
morbidity related to ERC
Time frame: within 12 months of ERC
stricture recurrence post ERC
Time frame: 12 months post ERC
Development of ascites post erc
Time frame: up to 12 months post ERC
Need for liver transplantation
Time frame: up to 12 months following ERC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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PSC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DEEPAK JOSHI, PhD principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing archimedes stent in people with Primary Sclerosing Cholangitis (PSC), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deployment of biodegradable stent placement across stricture at ERC in 20 patients (time frame: at time of primary ERC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.