ISRCTN15518794进行中（未招募）未知
Characterising the burden and clinical trajectory of pruritus in primary sclerosing cholangitis and non-cholestatic chronic liver disease
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •For the PSC group:
- •1. Must have a diagnosis of PSC
- •2. Either, subjects attending liver medicine clinic; or registered participants within the nationwide UK-PSC study
- •Non PSC group:
- •1. Subjects attending the liver or gastroenterology medicine clinic or healthy participants (no present or previous diagnosis of liver disease or IBD)
- •2. Diagnosis of following liver diseases; metabolic/non-alcoholic fatty liver disease, alcohol induced liver disease, chronic viral hepatitis, drug-induced liver disease, autoimmune hepatitis, genetic disorders of cholestasis
- •3. Diagnosis of IBD
- •4. Healthy participants who have no present or previous diagnosis of liver disease or inflammatory bowel disease
排除标准
- •1. Age <16 years
- •2. Women who are pregnant or lactating
- •3. Lack of capacity (as deemed by the investigator) to provide an accurate medical history
- •4. Not able to communicate in English and no translator available
- •5. Small duct PSC without concomitant inflammatory bowel disease (IBD)
- •6. Other causes of chronic liver disease including
- •6.1. IgG4-related disease
- •6.2. Primary biliary cholangitis (PBC)
- •6.3. Secondary sclerosing cholangitis
- •6.4. Fatty liver disease
- •6.5. Habitual alcohol consumption greater than 21 oz/week for men or 14 ox/week for women
- •6.6. HIV infection
- •6.7. Drug-induced liver disease
- •6.8. Genetic disorders of cholestasis
- •6.9. Wilson disease
- •6.10. Alpha-1-antitrypsin deficiency
- •6.11. Hepatic veno-occlusive disease, including portal vein thrombosis or Budd-Chiari syndrome
- •7. History of liver transplantation
- •8. Current or prior history of cholangiocarcinoma, pancreatic or hepatocellular cancer
- •9. Gallbladder cancer in the previous 12 months
- •10. Colorectal cancer (or evidence of active metastatic disease) in the previous twelve months
- •11. Chemo- or radiotherapy in the previous twelve months
- •12. Chronic kidney disease, defined by the use of renal replacement therapy or a urea >20 mmol/l
- •Non PSC Group:
- •1. Age <16 years
- •2. Women who are pregnant or lactating
- •3. Lack of capacity (as deemed by the investigator) to provide an accurate medical history
- •4. Not able to communicate in English and no translator available
- •5. Radiological evidence of cholangiography including secondary sclerosing cholangitis
- •6. Histological evidence of inflammatory bile duct lesions or periductal fibrosis
- •7. Mixed aetiology of liver disease
- •8. Other causes of chronic liver disease:
- •8.1. Primary biliary cholangitis (PBC)
- •8.2. Primary sclerosing cholangitis (PSC)
- •8.3. HIV infection
- •8.4. Wilson disease
- •8.5. Alpha-1-antitrypsin deficiency
- •8.6. Hepatic veno-occlusive disease, including portal vein thrombosis or Budd-Chiari syndrome
- •9. History of liver transplantation
- •10. Current or prior history of cholangiocarcinoma, pancreatic or hepatocellular cancer
- •11. Gallbladder cancer in the previous 12 months
- •12. Colorectal cancer (or evidence of active metastatic disease) in the previous twelve months
- •13. Chemo- or radiotherapy in the previous twelve months
- •14. Chronic kidney disease, defined by the use of renal replacement therapy or a urea >20 mmol/l
- •15. Other known dermatological, haematological or extrahepatic disorder, including iatrogenic causes (e.g. excessive opioid use) associated with pruritus; investigator discretion
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