Biodegradable Stents in Primary Sclerosing Cholangitis (BSTPSC)
27 maj 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
London, Storbritannien, SE5 9RS
- Rekrytering
- King's College Hospital, London
-
Kontakt:
- D Joshi, PhD
- Telefonnummer: 02032999000
- E-post: d.joshi@nhs.net
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Archimedes stent insertion
Archimedes stent insertion at ERCP for patients with PSC and a HGS
|
archimedes stent for HGS
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
Tidsram: at time of primary ERC
|
Deployment of stent across the stricture - yes or no
|
at time of primary ERC
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
Tidsram: 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)
Tidsram: Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
change in pruritus, fatigue, pain and fever
|
Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
|
Mortality over 12 months.
Tidsram: Within 12 months of primary ERCP
|
Death related to PSC
|
Within 12 months of primary ERCP
|
|
morbidity related to ERC
Tidsram: within 12 months of ERC
|
Complications including cholangitis and pancreatitis post ERC
|
within 12 months of ERC
|
|
stricture recurrence post ERC
Tidsram: 12 months post ERC
|
Development of a stricture in the bile duct
|
12 months post ERC
|
|
Development of ascites post erc
Tidsram: up to 12 months post ERC
|
development of abdominal ascites post ERC
|
up to 12 months post ERC
|
|
Need for liver transplantation
Tidsram: up to 12 months following ERC
|
patients who are assessed and then listed for liver transplant
|
up to 12 months following ERC
|
|
Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
Tidsram: 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
|
|
Change in quality fo life as assessed by the Short form-36 (SF-36
Tidsram: after ERC and assesment at 2 weeks, 12 weeks and 12 months
|
Change in QoL
|
after ERC and assesment at 2 weeks, 12 weeks and 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: DEEPAK JOSHI, PhD, King's College Hospital NHS Trust
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2026
Primärt slutförande (Beräknad)
1 april 2027
Avslutad studie (Beräknad)
1 april 2027
Studieregistreringsdatum
Först inskickad
20 april 2026
Först inskickad som uppfyllde QC-kriterierna
20 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRAS 336318
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