Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis

Phase 3

• Conditions: Variceal bleeding in liver cirrhosis; Digestive System

• Registration Number: ISRCTN73887615
• Lead Sponsor: niversity of Birmingham

Brief Summary

2019 Protocol article in https://doi.org/10.1136/bmjgast-2019-000290 protocol (added 24/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-10
• Last Update Posted: 9 January 2023
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

1. Liver cirrhosis as defined clinically, radiologically (USS and transient elastography), or on histology
2. Medium varices (Grade II varices that do not flatten on air insufflation and do not occlude the lumen) and large varices (Grade III varices which are larger than Grade II varices and occupy the whole lumen) that have never bled as defined in the BSG guidelines
3. Aged 18 years or older

Exclusion Criteria

Current exclusion criteria as of 24/11/2021:
1. Age <18 years
2. Pregnant or lactating women
3. Known intolerance or contraindications to beta-blockers including asthma
4. Current or past history of non-selective beta-blocker use (such as carvedilol, nadolol or propranolol)
5. Current or history of variceal band ligation
6. Presence of malignancy or systemic disease that significantly affects 1-year survival
7. Unable to give informed consent
8. Diagnosed with acute alcoholic hepatitis at the point of randomisation
9. Patients with surgical or radiological portosystemic shunts such as transjugular portosystemic stent-shunt (TIPSS)
10. Previous organ transplantation

Previous exclusion criteria:
1. Pregnant or lactating women
2. Known allergy to carvedilol
3. Already on non-selective beta-blockers that could not be discontinued
4. Presence of malignancy or systemic disease that significantly affects 1-year survival
5. Unable to give informed consent
6. Contraindications to beta-blockers including asthma
7. Acute alcoholic hepatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any variceal bleeding within 12 months of randomisation, assessed through endoscopy for the variceal band ligation (VBL) and through observation for the carvedilol arm at 4 weeks and after 6 and 12 months