Assessment of itch symptoms in primary sclerosing cholangitis and other chronic liver diseases

Not Applicable

• Conditions: Pruritus in primary sclerosing cholangitis, non-cholestatic chronic liver disease, inflammatory bowel disease; Digestive System

• Registration Number: ISRCTN15518794
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-20
• Last Update Posted: 29 January 2024
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

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

Exclusion Criteria

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. 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Exploratory primary outcome:<br> The prevalence and long-term variability of pruritus over 48 weeks in patients with primary sclerosing cholangitis. Pruritus is measured using the numerical rating scale (NRS), 5d itch scale and the Simple Cholestatic Complaints Score at baseline, 12, 24, 36 and 48 weeks.<br>