Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Research has proven that large varices can be treated with beta-blockers (a type of anti-hypertensive medication) to reduce the pressure in the veins. The management of small varices is still uncertain. This study aims to discover if beta blockers can be used in this setting. We hypothesize that beta blockers will reduce the risk of bleeding from small varices from 20% to 10% over a period of 3 years, resulting in significant cost savings to the NHS from better patient outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Collaborators: Brighton and Sussex University Hospitals NHS Trust; Cardiff University; King's College London
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• Age 18 years and over

• Cirrhosis and portal hypertension,

• Small oesophageal varices diagnosed within the last 6 months, defined as ≤5 mm in diameter or varices which completely disappear on moderate insufflation at gastroscopy.

• Not received a beta-blocker in the last week

• Capacity to provide informed consent

Exclusion Criteria:

• Non-cirrhotic portal hypertension

• Medium/large oesophageal varices (current or history [decreasing in size without curative therapy]), defined as >5 mm in diameter

• Gastric (IGV and GOV2), duodenal, rectal varices with or without evidence of recent bleeding.

• Previous variceal haemorrhage

• Previous band ligation or glue injection of oesophageal and/or gastric varices

• Red signs accompanying varices at endoscopy

• Known intolerance to beta blockers

• Contraindications to beta blocker use

• Unable to provide informed consent

• Child Pugh C cirrhosis

• Already receiving a beta-blocker for another reason that cannot be discontinued

• Graft cirrhosis post liver transplantation

• Evidence of active malignancy without curative therapy planned

• Pregnant or lactating women

• Women of child bearing potential not willing to use adequate contraception during the period of IMP dosing

• Patients who have been on a CTIMP within the previous 3 months

• Clinical symptoms consistent with COVID-19