Primary Sclerosing Cholangitis (PSC)
Conditions
Keywords
PSC, ERCP, Biodegradable stents
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.
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
DEVICEarchimedes stent
archimedes stent for HGS
Sponsors
King's College Hospital NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deployment of biodegradable stent placement across stricture at ERC in 20 patients | at time of primary ERC | Deployment of stent across the stricture - yes or no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative recurrence -free rate of primary high grade strictures within 12 months. | through study completion up to 12 months | has the stricture reoccured (yes or no) at 12 months post ERC and stent |
| 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. | change in pruritus, fatigue, pain and fever |
| 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 liver blood tests: \- ALP, AST, ALT, Bilirubin |
| 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 | Change in QoL |
| Mortality over 12 months. | Within 12 months of primary ERCP | Death related to PSC |
| morbidity related to ERC | within 12 months of ERC | Complications including cholangitis and pancreatitis post ERC |
| stricture recurrence post ERC | 12 months post ERC | Development of a stricture in the bile duct |
| Development of ascites post erc | up to 12 months post ERC | development of abdominal ascites post ERC |
| Need for liver transplantation | up to 12 months following ERC | patients who are assessed and then listed for liver transplant |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDEEPAK JOSHI, PhD
King's College Hospital NHS Trust
Outcome results
None listed