Using beta-blockers to prevent bleeding from small esophageal varices in cirrhosis patients
Beta-blockers Or Placebo for Primary Prophylaxis of Oesophageal Varices (BOPPP Trial). A Blinded, UK Multi-centre, Clinical Effectiveness and Cost-effectiveness Randomised Controlled Trial.
This study is testing whether beta-blockers can help prevent bleeding from small esophageal varices in patients with cirrhosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05872698 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with cirrhosis, portal hypertension, and small esophageal varices diagnosed within the last six months.
Not a fit: Patients with medium or large varices, previous variceal hemorrhage, or contraindications to beta-blocker use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of life-threatening bleeding in patients with small esophageal varices.
How similar studies have performed: Previous studies have shown that beta-blockers are effective for large varices, but this approach for small varices is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- King's College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Ruhama Uddin
- Email: kch-tr.boppptrial@nhs.net
- Phone: 0203 299 7142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.