Clinical Trials

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.

Minimising Mortality from Alcoholic Hepatitis

The MRC Stratified Medicine application entitled ‘Minimising Mortality from Alcoholic Hepatitis’ will commence in April 2018 and will last for 5 years. The award was for £5M and will involve Imperial College (Mark Thursz, Harry Antonaides, Elaine Holmes), University of Birmingham (David Adams, Trish Lalor, Chris Weston), University College London (William Rosenberg), MRC Biostatistics Unit Cambridge (Paul Newcombe), University of Edinburgh (Stuart Forbes) and University of Plymouth (Ashwin Dhanda) as well as the 40 clinical sites recruiting patients.

Read more on the BSG website > here.

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.

 

 

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