Biodegradable Stents in Primary Sclerosing Cholangitis
ConditionPrimary Sclerosing Cholangitis (PSC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
PSC patients with a high grade stricture
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
archimedes stent
Devicearchimedes stent for HGS
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Archimedes stent insertionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
Deployment of stent across the stricture - yes or no
Time frame
at time of primary ERCSecondary outcomes
1
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
has the stricture reoccured (yes or no) at 12 months post ERC and stent
Time frame
through study completion up to 12 months2
Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
change in pruritus, fatigue, pain and fever
Time frame
Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.3
Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
Change in liver blood tests: \- ALP, AST, ALT, Bilirubin
Time frame
At week 2 and 12 weeks post ERCP4
Change in quality fo life as assessed by the Short form-36 (SF-36
Change in QoL
Time frame
after ERC and assesment at 2 weeks, 12 weeks and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov