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

Design

Randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis.

Sponsor:   University of Birmingham

Chief Investigator:   Dr. Dhiraj Tripathi

Coordinating Centre:   Birmingham Clinical Trials Unit

Funder:   National Institute for Health Research (NIHR)

                 Health and Technologies Assessment (HTA) Programme

Aim of Study

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.

Setting

Acute NHS Trusts across the UK.

Target population

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.

Intervention

Patients will be randomised to treatment with variceal band ligation or 12.5 mg carvedilol once daily.