Biodegradable Stents in Primary Sclerosing Cholangitis

NCT07607353 | Recruiting

• 1 other identifier: IRAS 336318
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

PSC; ERCP; Biodegradable stents

Outcome Measures

Primary Outcomes (1)

• Deployment of biodegradable stent placement across stricture at ERC in 20 patients

  Deployment of stent across the stricture - yes or no

  at time of primary ERC

Secondary Outcomes (9)

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

  through study completion up to 12 months

• Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)

  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.

  At week 2 and 12 weeks post ERCP

• Change in quality fo life as assessed by the Short form-36 (SF-36

  after ERC and assesment at 2 weeks, 12 weeks and 12 months

• Mortality over 12 months.

  Within 12 months of primary ERCP

Study Arms (1)

Archimedes stent insertion

EXPERIMENTAL

Archimedes stent insertion at ERCP for patients with PSC and a HGS

Device: archimedes stent

Interventions

archimedes stent DEVICE

archimedes stent for HGS

Archimedes stent insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSC patients with a high grade stricture

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital, London

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• DEEPAK JOSHI, PhD

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-04

Locations

GB (1)