A multicentre randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in patients with liver cirrhosis and medium to large oesophageal varices.

Sponsor:   University of Birmingham

Chief Investigator:   Prof. Dhiraj Tripathi

Coordinating Centre:   Birmingham Clinical Trials Unit

Funder:   National Institute for Health Research (NIHR)

                 Health and Technologies Assessment (HTA) Programme

To investigate the clinical and cost-effectiveness of carvedilol versus variceal band ligation in patients with cirrhosis and medium to large oesophageal varices that have not bled.

Acute NHS Trusts across the UK.

Adult patients with liver cirrhosis as defined clinically, radiologically (USS and transient elastography), or histology and 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 will be eligible to be recruited.

Study Duration: CALIBRE is now closed to recruitment.

Patients will be randomised to treatment with variceal band ligation or 12.5 mg carvedilol once daily which are both currently recommended treatments.