Endoscopic Therapy in Patients With Primary Sclerosing Cholangitis: 30 Years of Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Effectiveness of long-term endoscopic treatment
研究概览
简要总结
Primary Sclerosing Cholangitis (PSC) is a chronic, cholestatic, immune-mediated liver disease characterized by segmental inflammation, fibrosis and destruction of the intra and / or extrahepatic biliary tree.
Patients suffering from PSC can develop biliary strictures and symptoms (jaundice, itching, cholangitis) requiring endoscopic therapy by Endoscopic Retrograde Cholangiopancreatography (ERCP).
ERCP can play an important role in symptoms control, cholangiocarcinoma diagnosis.
PSC can lead to liver failure and subsequent need for liver transplantation, ERCP can therefore delay the time for liver transplantation.
With this work the investigators want to report our thirty years of experience in the endoscopic treatment of PSC.
详细描述
Population studies have provided an estimation of prevalence which is between 1-16 per 100,000 inhabitants. PSC occurs mainly in young adults between the ages of 25 and 45, although it can occur at any age.
There is a strong correlation between CSP and Chronic Inflammatory Bowel Diseases.
The etiology of PSC is not known, although its autoimmune origin is commonly accepted.
The onset of PSC is symptomatic in about 50% of cases and the presentation can range from non-specific symptoms (fatigue, itching, low-grade fever), to cholangitis or even to symptoms and signs of liver cirrhosis.
Of the imaging tests, MRCP , is the most accurate in the diagnosis of PSC and should be accompanied by periodic non-invasive evaluations of associated hepatic fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients diagnosed with PSC and biliary tract stenosis with indication for endoscopic treatment.
排除标准
- •Patients with unclear diagnosis of PSC.
- •Patients ineligible for endoscopic therapy.
结局指标
主要结局
Effectiveness of long-term endoscopic treatment
时间窗: From Enrollment to the last follow-up, 3 years
PSC can lead to liver failure and need for liver transplantation. Endoscopic therapy can have a positive impact to delay the need for liver transplantation
次要结局
- Need for Endoscopic retreatment(From Enrollment to the last follow-up, 3 years)
- Occurrence of Cholangiocarcinoma(From Enrollment to the last follow-up, 3 years)
- Adverse events(From Enrollment to the last follow-up, 3 years)
研究者
Tringali Andrea, MD, PhD
Assistant Professor of Surgery
Fondazione Policlinico Universitario Agostino Gemelli IRCCS