Beta-blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP): a blinded, multi-centre, clinical effectiveness and cost-effectiveness randomised controlled trial

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Participants with cirrhosis and small varices without evidence of previous bleeding
Sponsor: King’s College Hospital NHS Foundation Trust
Enrollment: 763
Status: Active, not recruiting
Last Updated: last year

2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35113923/ results of the embedded qualitative study (added 04/02/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36251653/ results of the embedded qualitative study (added 18/10/2022) 2024 Protocol article in https://doi.org/10.1186/s13063-024-08063-3 (added 17/04/2024)

Registry

who.int

Start Date

December 4, 2018

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Age \>18 years
•2\. Cirrhosis and portal hypertension, defined by any two of the following:
•2\.1\. Characteristic clinical examination findings; one or more of:
•2\.1\.1\. Jaundice, ascites, caput medusae, spider naevi, palmar erythema, asterixis
•2\.2\. Characteristic liver function tests, haematological panel and coagulation profile abnormalities
•2\.2\.1\. hyperbilirubinaemia (serum total bilirubin \> 30 umol/l)
•2\.2\.2\. thrombocytopenia (platelet count \<120 x109 / L)
•2\.2\.3\.international normalised raio (INR) \> 1\.5
•NB These blood tests may be normal in well compensated cirrhosis – if cirrhosis is confirmed on other investigations, normal blood tests suggest well compensated disease.
•2\.3\. Characteristic radiological findings; one or more of:

•1\. Non\-cirrhotic portal hypertension
•2\. Medium/large oesophageal varices (current or history of)
•3\. Isolated gastric, duodenal, rectal varices with or without evidence of recent bleeding
•4\. Previous variceal haemorrhage
•5\. Known intolerance to beta blockers
•6\. Contraindication to beta blocker use:
•6\.1\. Heart rate \<50 bpm
•6\.2\. Known 2nd degree or higher heart block
•6\.3\. Sick sinus syndrome
•6\.4\. Systolic blood pressure \<85mm Hg