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

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · May 23, 2023

Keywords

ClinConnect Summary

The Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) Trial is studying whether beta-blockers, a type of medication that helps lower blood pressure, can help prevent bleeding from small varices in patients with liver cirrhosis. Varices are swollen veins that can form in the esophagus (the tube that connects the throat to the stomach) due to increased pressure in the liver. This study aims to see if taking beta-blockers can reduce the chance of bleeding from these small varices over three years, potentially improving patient outcomes and saving costs for healthcare services.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with cirrhosis and portal hypertension, along with having small esophageal varices. If you have had medium or large varices, or if you have received certain treatments for varices in the past, you may not be eligible. Participants will take either the beta-blocker or a placebo (a dummy treatment) and will be monitored throughout the study. This research is important because it could lead to better management of patients with small varices, which is currently uncertain.

Gender

ALL

Eligibility 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