Active not recruitingPHASE4INTERVENTIONAL

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

This study, called BOPPP, is investigating if a common blood pressure medicine called a beta-blocker can prevent serious bleeding from small, swollen veins (varices) in the food pipe of people with liver scarring, known as cirrhosis. Cirrhosis is a serious liver condition affecting many people in the UK, and bleeding from these varices can be life-threatening. We already know that beta-blockers can help prevent bleeding if the varices are large, but their benefit for small varices is still unknown. Participants with small varices will be randomly given either the beta-blocker or a dummy pill (placebo) and observed for three years. The goal is to see if beta-blockers can reduce the risk of bleeding from 20% to 10% and improve care for people with cirrhosis.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

King's College Hospital NHS Trust

Enrolment target

763

Start

01 Apr 2019

Estimated completion

01 Dec 2026

Cirrhosis, Liver Portal Hypertension Variceal Hemorrhage Varices, Esophageal

What is this study about?

In the UK, many people live with liver scarring, a condition called cirrhosis. This can lead to various health problems, and one very serious concern is bleeding from swollen veins in the food pipe, also known as the oesophagus. These swollen veins are called varices.

When these varices are large, doctors know that a type of medicine called a beta-blocker can help by lowering the pressure in these veins and reducing the risk of bleeding. However, for people who have small varices, doctors are not certain if beta-blockers are helpful. This study wants to answer that important question. We believe that using beta-blockers could reduce the chance of bleeding from small varices significantly, which could improve the lives of many people with cirrhosis and reduce costs for the NHS.

Over the next three years, we will carefully watch participants to see if taking a beta-blocker, compared to a dummy pill, reduces the risk of bleeding from their varices or causes any side effects. The results of this study could change how small varices are treated in the future, providing clearer guidance for doctors and better outcomes for patients.

Key takeaways

This study investigates if beta-blockers prevent bleeding from small varices in people with cirrhosis.
Participants will take either a beta-blocker or a placebo for three years.
Regular check-ups and yearly camera tests (endoscopies) are part of the study.
The findings could improve care for people with liver scarring.
You have the right to leave the study at any time.

Who may be eligible?

You might be able to join this study if you are 18 years or older and have liver scarring (cirrhosis) along with high blood pressure in your liver (portal hypertension). A doctor must have found small swollen veins (oesophageal varices) in your food pipe, measuring 5mm or less, within the last six months. Importantly, you shouldn't have taken a beta-blocker medicine in the week before joining, and you must be able to understand the study and agree to take part.

However, you cannot take part if your liver condition is very severe (Child Pugh C cirrhosis) or if you've had previous bleeding from these veins. You also can't join if you have medium or large varices, or if you've already had treatments like banding or glue injections for them. If you have other types of swollen veins, certain heart conditions, are pregnant or breastfeeding, or have active cancer, this study won't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have liver scarring (cirrhosis) and high liver blood pressure?
Have you been diagnosed with small varices (swollen veins) in your food pipe within the last 6 months?
Have you NOT taken a beta-blocker medicine in the past week?
Are you able to understand the study information and agree to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either a beta-blocker medicine or a dummy pill (placebo). Neither you nor your doctor will know which one you are taking. You'll take this medicine daily for three years. During this time, you'll have check-ups every six months. These check-ups will include reviewing your general health and how you're feeling. At the beginning of the study and then once a year, you will also have a camera test called an endoscopy, which involves a small camera being passed down your throat to look at your varices. We will also ask for your thoughts and experiences about taking part in the study and about any side effects you might have had.

Potential risks and benefits

The main potential benefit of taking part is that the beta-blocker might reduce your risk of bleeding from varices, which is a serious complication of cirrhosis. This study could help us learn more about treating small varices, which benefits future patients. Potential risks include feeling side effects from the beta-blocker, such as tiredness, dizziness, or a slower heartbeat, amongst others, or from the endoscopy procedure. Taking a placebo means you might not receive an active treatment for small varices, but we don't currently know if treatment is needed for small varices. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

King's College Hospital
Verified postcode
London, United Kingdom

Common questions

What are varices?

Varices are swollen veins, usually in the food pipe (oesophagus), that can develop when you have liver scarring (cirrhosis). They can sometimes bleed.

What is a beta-blocker?

A beta-blocker is a type of medicine often used to lower blood pressure and slow the heart rate. In this study, we're looking if it reduces pressure in specific veins.

What does 'randomised to placebo' mean?

It means you'll be randomly chosen to receive either the actual beta-blocker medicine or a dummy pill (placebo) that looks the same but contains no active drug. This helps us fairly compare the effects.

How long will the study last for me?

If you join, you will be part of the study for three years, with regular check-ups and yearly camera tests.

Will I know if I'm taking the real medicine or the dummy pill?

No, neither you nor your doctor will know whether you are receiving the beta-blocker or the placebo during the study. This is called 'blinding' and helps keep the study fair.