Completed Heart, Stroke & Blood Digestion, Kidneys & Other Organs

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

In plain English

AI plain-English summary

A large UK trial has now finished recruiting 2,630 patients with liver cirrhosis to determine whether the drug carvedilol is better than a routine endoscopic procedure at preventing their first variceal bleed. Bleeding from swollen veins in the oesophagus is a life-threatening complication of cirrhosis. Both carvedilol (a beta-blocker that lowers pressure in these veins) and variceal band ligation (where a doctor places rubber bands around the veins during an endoscopy) are currently recommended for prevention, but doctors do not know which works best. The CALIBRE trial directly compares the two in a head-to-head randomised study across multiple NHS hospitals. If carvedilol proves superior or non-inferior to band ligation, it could shift clinical practice toward a simpler, drug-based approach that avoids repeated endoscopic procedures. This would reduce patient discomfort, free up endoscopy appointments, and lower NHS costs. The trial also includes a health economic evaluation, so funders will have clear data on cost-effectiveness. Results are expected to inform updated UK guidelines on managing varices in cirrhosis.

View original technical description
Design: A multicentre randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in patients with cirrhosis and medium to large oesophageal varices. There will be an internal pilot and a health economic evaluation. Setting: Gastroenterology/Hepatology Hospital Departments, mainly outpatient clinic and endoscopy settings in acute NHS Trusts across the UK. Target populations: Patients aged 18 and over with liver cirrhosis and medium to large varices that have never bled. Health technologies: Carvedilol and variceal band ligation, which are currently both recommended treatments. Sample Size: 2630 patients (1:1 randomisation) based on a superiority hypothesis with power 90%, alpha 0.05 and allowing for 10% dropout. Study Duration: CALIBRE is now closed to recruitment. Expertise of the team: Leading clinical experts in the field who have conducted similar research in the past. The Clinical Trials Unit comprises the Director, statistician, and trial coordinators, with links to health economist and trial coordinators.

Related Research

Grants with similar aims, by meaning.

Beta-blockers or placebo for primary prophylaxis of oesophageal varices (BOPPP study)
CArvediloL versus variceal Band ligation in primary pREvention of variceal bleeding in liver cirrhosis
Randomised controlled trial of carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis
Beta-blockers or placebo for primary prophylaxis of oesophageal varices. A blinded, multi-centre, clinical effectiveness and cost-effectiveness randomised controlled trial
Beta blockers Or Placebo for Primary Prophylaxis of oesophageal varices in cirrhosis (BOPPP). A triple blinded, multi-centre, clinical and cost-effectiveness randomised controlled trial.

Original classification

Research

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.