Clinical Trials
Refractory Ascites: Management and Outcomes - a National Audit' (RAMONA)
RAMONA is a trainee-led national audit looking at how patients with refractory ascites are being managed (i.e. liver transplant, TIPS, long-term ascitic drain or LVPs) and what their outcomes are. Our outcome measures include 6-/12-month mortality, readmission rates as well as palliative care involvement.
Site registration period: 20th January 2025 - 30th June 2025
Data submission deadline: 30th November 2025
If you would like to learn more or take part in this audit, please send the RAMONA team an email to Ben To (b.to@nhs.net ) for more information.
Thank you and we look forward to hearing from you!
REACT-AVB - Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding
ISRCTN85274829
Chief Investigator: Professor Dhiraj Tripathi
Co-Chief Investigator: Dr David Patch
The research question: “Does early TIPSS within 4 days of an acute variceal bleed result in improved transplant free patient survival when compared with standard of care?”
Objectives:
To investigate the clinical and cost-effectiveness of early transjugular intrahepatic portosystemic stent-shunt (TIPSS) versus endoscopic plus pharmacological therapy in patients with cirrhosis and acute variceal bleeding after initial control of bleeding by variceal band ligation (VBL).
Trial design:
Pragmatic multicentre randomised controlled open label superiority two arm parallel group trial with an internal pilot.
Patient population:
Patients with liver cirrhosis presenting with acute variceal bleeding which has been controlled by current therapy as recommended in the British Society of Gastroenterology (BSG) guidelines.
Sample size: 294 patients (1:1 randomisation).
Funding: NIHR-HTA programme. Award ID: NIHR130883. £1.26m
Sponsor: University of Birmingham
Setting: Acute NHS Trusts and Health Boards in the UK that admit and manage patients with acute variceal bleeding.
Protocol: https://njl-admin.nihr.ac.uk/document/download/2044563
Contacts: react-avb@trials.bham.ac.uk
Website: REACT-AVB - University of Birmingham
Twitter/X: @AvbReact
REDUCe 2 (REpeated Drainage in Untreatable Cirrhosis) Study
REDUCe 2 study is a NIHR HTA funded multicentre trial following on from the earlier feasibility REDUCe Study(Macken L et al, APT 2020). The REDUCe 2 study is a randomised controlled trial comparing palliative long-term abdominal drains vs. large volume paracentesis in patients with refractory ascites due to cirrhosis. Recruitment commences Sept/Oct 2022 and will continue until June 2026. The study will be conducted across 35 sites in England and Scotland. If you are interested in participating please contact the Chief Investigator Sumita Verma (s.verma@bsms.ac.uk). The study abstract can be found by clicking on the link below.
Download REDUCe 2 abstract for BASL website PDF.pdf
Beta Blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP)
This is a UK-wide multi-centre randomised controlled trial. It will address whether primary prophylaxis against all-cause decompensation with non-selective beta blockers is clinically and economically effective in patients with cirrhosis and small varices. The National Institute of Health Research Health Technology Assessment (NIHR: HTA) programme commissioned this research with funding secured of £2.5 million to consent, treat and follow up 740 patients at multiple hospitals across the UK. The trial is led by the Institute of Liver Sciences, Kings College Hospital and Kings College London Clinical Trials Unit. BOPPP will be one of the largest ever portal hypertension trials in this group of patients, and is currently (February 2024) being run at 55 UK-wide sites, nearing completion of recruitment.
Please contact kch-tr.boppptrial@nhs.net for further information
BOPPP Trial Manager: Ruhama Uddin
Telephone: 020 3299 7142
Twitter: @boppptrial
Website: BOPPP Trial (boppp-trial.org)
Further information is also available in this link: Boppp-trial.org/synopsis2023
ASEPTIC (Primary Antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis)
ASEPTIC is an NIHR HTA funded multi-centre trial to examine the efficacy of primary prophylaxis using the narrow spectrum antibiotic Co-Trimoxazole in patients with cirrhosis and ascites.
We are still looking for sites and the study will run for the next 4 years. Please contact ctu.ASEPTIC@ucl.ac.uk for more details.
For more information: Download ASEPTIC trial information for BSG and BASL.pdf.
PRIMER-1 Study - Perioperative pembrolizumab and lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
This is a phase II randomised open-label study in Hepatocellular carcinoma (HCC). It is run by the CR UK & UCL Cancer Trials Centre and funded by Merck, Sharp & Dhome (MSD). PRIMER-1 will recruit patients from approximately 10 sites across the UK and the recruitment target is 60 patients over a period of 2 years.
The 3 groups are:
- pembrolizumab before surgery
- lenvatinib before surgery
- pembrolizumab and lenvatinib before surgery
After surgery everyone has pembrolizumab every 3 weeks for up to a year.
The aims of the trial are to find out:
- how well these treatments work
- whether these treatments reduce the chances of liver cancer coming back after surgery
- what the side effects are and if they are manageable
- whether the side effects might delay surgery
Please contact ctc.primer1@ucl.ac.uk for further information.
PRIMER-1 Trial Manager: Michelle Hung.
