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Recruiting NCT07607353

Biodegradable Stents in Primary Sclerosing Cholangitis

No phase Interventional Primary Sclerosing Cholangitis (PSC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: archimedes stent.
Who it may be relevant to
Registry conditions: Primary Sclerosing Cholangitis (PSC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC

Overview

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.

Interventions

  • Device archimedes stent
    archimedes stent for HGS

Primary outcome measures

  • Deployment of biodegradable stent placement across stricture at ERC in 20 patients [Time frame: at time of primary ERC]
Secondary outcome measures (9)
  • 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • King's College Hospital, London — London

Identifiers

NCT: NCT07607353 · IRAS 336318

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗