Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial. (NCT05872698) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.
United Kingdom763 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, if relevant
* Patients who have been on a CTIMP within the previous 3 months
* Clinical symptoms consistent with COVID-19
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.