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New treatment option for Primary Sclerosing Cholangitis (PSC)
Official title Biodegradable Stents in Primary Sclerosing Cholangitis
ClinicalTrials.gov ID: NCT07607353
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PSC patients with a high grade stricture
You likely can't join 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
See the full eligibility criteria
- PSC patients with a high grade stricture
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.