Biodegradable Stents in Primary Sclerosing Cholangitis (BSTPSC)
2026年5月27日 更新者：King's College Hospital NHS Trust
Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
London、英国、SE5 9RS
- 招聘中
- King's College Hospital, London
-
接触：
- D Joshi, PhD
- 电话号码：02032999000
- 邮箱：d.joshi@nhs.net
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Archimedes stent insertion
Archimedes stent insertion at ERCP for patients with PSC and a HGS
|
archimedes stent for HGS
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Deployment of biodegradable stent placement across stricture at ERC in 20 patients
大体时间：at time of primary ERC
|
Deployment of stent across the stricture - yes or no
|
at time of primary ERC
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative recurrence -free rate of primary high grade strictures within 12 months.
大体时间：through study completion up to 12 months
|
has the stricture reoccured (yes or no) at 12 months post ERC and stent
|
through study completion up to 12 months
|
|
Change in symptoms as assessed by the Amsterdam cholestatic complaints score (ACCS)
大体时间：Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
change in pruritus, fatigue, pain and fever
|
Post ERC to assessment at 2 weeks and 12 weeks, and at 12 months.
|
|
Mortality over 12 months.
大体时间：Within 12 months of primary ERCP
|
Death related to PSC
|
Within 12 months of primary ERCP
|
|
morbidity related to ERC
大体时间：within 12 months of ERC
|
Complications including cholangitis and pancreatitis post ERC
|
within 12 months of ERC
|
|
stricture recurrence post ERC
大体时间：12 months post ERC
|
Development of a stricture in the bile duct
|
12 months post ERC
|
|
Development of ascites post erc
大体时间：up to 12 months post ERC
|
development of abdominal ascites post ERC
|
up to 12 months post ERC
|
|
Need for liver transplantation
大体时间：up to 12 months following ERC
|
patients who are assessed and then listed for liver transplant
|
up to 12 months following ERC
|
|
Clinical success is defined by improvement in liver function tests (LFT) by 20% at week 2 and week 12.
大体时间：At week 2 and 12 weeks post ERCP
|
Change in liver blood tests: - ALP, AST, ALT, Bilirubin |
At week 2 and 12 weeks post ERCP
|
|
Change in quality fo life as assessed by the Short form-36 (SF-36
大体时间：after ERC and assesment at 2 weeks, 12 weeks and 12 months
|
Change in QoL
|
after ERC and assesment at 2 weeks, 12 weeks and 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：DEEPAK JOSHI, PhD、King's College Hospital NHS Trust
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年4月1日
研究注册日期
首次提交
2026年4月20日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月29日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.