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NCT Number: NCT07607353

Biodegradable Stents in Primary Sclerosing Cholangitis

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.

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Key information

Conditions

Primary Sclerosing Cholangitis (PSC) Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital, London

London, SE5 9RS, United Kingdom

Location status: Recruiting

Location contact

D Joshi, PhD

CONTACT

[email protected]

02032999000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

archimedes stent

Device

archimedes stent for HGS

Primary outcomes

  1. 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

Secondary outcomes

  1. Cumulative recurrence -free rate of primary high grade strictures within 12 months.

    Time frame: through study completion up to 12 months

    has the stricture reoccured (yes or no) at 12 months post ERC and stent

  2. 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.

    change in pruritus, fatigue, pain and fever

  3. 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 liver blood tests:

    • ALP, AST, ALT, Bilirubin

  4. 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

    Change in QoL

  5. Mortality over 12 months.

    Time frame: Within 12 months of primary ERCP

    Death related to PSC

  6. morbidity related to ERC

    Time frame: within 12 months of ERC

    Complications including cholangitis and pancreatitis post ERC

  7. stricture recurrence post ERC

    Time frame: 12 months post ERC

    Development of a stricture in the bile duct

  8. Development of ascites post erc

    Time frame: up to 12 months post ERC

    development of abdominal ascites post ERC

  9. Need for liver transplantation

    Time frame: up to 12 months following ERC

    patients who are assessed and then listed for liver transplant

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC

Acronym: BSTPSC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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