CALIBRE - Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis

Trial Design: A multicentre randomised controlled, open-label, self-evident two-arm trial with internal pilot.
Aim: To investigate the clinical and cost-effectiveness of carvedilol versus variceal band ligation in patients with cirrhosis and medium to large oesophageal varices that have not bled.
Sample size: 2630 – CALIBRE is largest ever Phase III trial in cirrhosis.
Funding: NIHR HTA funded - £2.3m. Sponsor is University of Birmingham.
Recruitment: Over 4 years nationally. All acute NHS trusts and health boards in UK are potentially eligible
Primary end point: Any variceal bleeding within 1 year of randomisation. Full protocol has been published: https://bmjopengastro.bmj.com/content/6/1/e000290 

For further information and details of how your site can participate in CALIBRE please contact calibretrial@trials.bham.ac.uk . The CALIBRE website provides full details: https://www.birmingham.ac.uk/research/bctu/trials/portfolio-v/CALIBRE/CALIBRE.aspx 

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 future variceal haemorrhage 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 £2.3 million to consent, treat and follow up 1,200 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 (March 2020) being run at 24 UK-wide sites, with a further 25 sites being invited to open to recruitment over the next 6 months.

Please contact kch-tr.boppptrial@nhs.net for further information and for details of how your site can participate in BOPPP.

Further information is also available in this link:  Download BOPPP_Summary_Feb2020.pdf

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 the chief Investigator Alastair O’Brien via email a.o’brien@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.

Receipt of Curative Resection or Palliative Care for Hepato-pancreatico-biliary tumours

Pancreatic adenocarcinoma is a leading cause of cancer death in the UK. 80% of patients with pancreatic cancer present with unresectable disease. There is considerable regional variation in the diagnostic pathway for patients with pancreatic and other peri-ampullary cancers, and differing strategies for the management of malignant biliary obstruction.

The aim of this study is to map the management pathway including investigations, biliary decompression and surgery from presentation to 90-day outcome for patients with pancreatic or peri-ampullary cancers as well as those with malignant biliary obstruction.

Read more on the BSG website > here.

Now recruiting: Trial of Faecal Microbiota Transplantation (FMT) in Cirrhosis (PROFIT-01)

The primary objective of this study will be to assess whether stabilising gut dysbiosis with FMT in patients with advanced cirrhosis is both feasible and safe. 

Read more on the BSG website > here

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