Biodegradable Stents in Primary Sclerosing Cholangitis (BSTPSC)
27. mai 2026 oppdatert av: King's College Hospital NHS Trust
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
London, Storbritannia, SE5 9RS
- Rekruttering
- King's College Hospital, London
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Ta kontakt med:
- D Joshi, PhD
- Telefonnummer: 02032999000
- E-post: d.joshi@nhs.net
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Archimedes stent insertion
Archimedes stent insertion at ERCP for patients with PSC and a HGS
|
archimedes stent for HGS
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
Tidsramme: at time of primary ERC
|
Deployment of stent across the stricture - yes or no
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at time of primary ERC
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
Tidsramme: through study completion up to 12 months
|
has the stricture reoccured (yes or no) at 12 months post ERC and stent
|
through study completion up to 12 months
|
|
Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
Tidsramme: Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
change in pruritus, fatigue, pain and fever
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Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
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Mortality over 12 months.
Tidsramme: Within 12 months of primary ERCP
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Death related to PSC
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Within 12 months of primary ERCP
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morbidity related to ERC
Tidsramme: within 12 months of ERC
|
Complications including cholangitis and pancreatitis post ERC
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within 12 months of ERC
|
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stricture recurrence post ERC
Tidsramme: 12 months post ERC
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Development of a stricture in the bile duct
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12 months post ERC
|
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Development of ascites post erc
Tidsramme: up to 12 months post ERC
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development of abdominal ascites post ERC
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up to 12 months post ERC
|
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Need for liver transplantation
Tidsramme: up to 12 months following ERC
|
patients who are assessed and then listed for liver transplant
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up to 12 months following ERC
|
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Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
Tidsramme: At week 2 and 12 weeks post ERCP
|
Change in liver blood tests: - ALP, AST, ALT, Bilirubin |
At week 2 and 12 weeks post ERCP
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Change in quality fo life as assessed by the Short form-36 (SF-36
Tidsramme: after ERC and assesment at 2 weeks, 12 weeks and 12 months
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Change in QoL
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after ERC and assesment at 2 weeks, 12 weeks and 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: DEEPAK JOSHI, PhD, King's College Hospital NHS Trust
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2026
Primær fullføring (Antatt)
1. april 2027
Studiet fullført (Antatt)
1. april 2027
Datoer for studieregistrering
Først innsendt
20. april 2026
Først innsendt som oppfylte QC-kriteriene
20. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRAS 336318
Plan for individuelle deltakerdata (IPD)
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