Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PSC patients with a high grade stricture
排除标准
- •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.