Using beta-blockers to prevent bleeding from small esophageal varices in cirrhosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of beta-blockers in preventing bleeding from small esophageal varices in patients with cirrhosis and portal hypertension. Participants with small varices will be randomly assigned to receive either beta-blockers or a placebo, and monitored over a three-year period for any bleeding events or complications. The study aims to determine if beta-blockers can reduce the risk of bleeding from 20% to 10%, potentially leading to significant healthcare cost savings. Regular assessments, including endoscopies, will be conducted to evaluate the condition of the varices throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• King's College Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Ruhama Uddin
• Email: kch-tr.boppptrial@nhs.net
• Phone: 0203 299 7142

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.