BMJ Open Gastroenterology (Mar 2024)
Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in Acute Variceal Bleeding (REACT-AVB trial)
- ,
- Faisal Khan,
- Simon Travis,
- Dhiraj Tripathi,
- Sue Jowett,
- Gemma Slinn,
- Steven Masson,
- Andrew King,
- Imran Patanwala,
- Ameet Dhar,
- Ruairi Lynch,
- Adrian Stanley,
- Hamish Ireland,
- Peter Hayes,
- Robert Driver,
- Laura Harrison,
- Tom Pembroke,
- David Patch,
- Dominic Yu,
- Janisha Patel,
- James Maurice,
- Matthew Armstrong,
- Joanna Leithead,
- Matthew J Armstrong,
- Nicholas Roslund,
- Mandy Lomax,
- Homoyon Mehrzad,
- Richard J Aspinall,
- Teik Choon See,
- Fidan Yousuf,
- Naaventhan Palaniyappan,
- Elizabeth Brettell,
- Jeremy Cobbold,
- Roger McCorry,
- Emily Lam,
- Jayshri Shah,
- Evangelia Fatourou,
- Edward Britton,
- Jude Morris,
- Catherine Moakes,
- Alisha Maher,
- Sukhwant Sehmi,
- Syed Alam,
- Victoria J Appleby,
- Jagadish Nagaraj
Affiliations
- Faisal Khan
- Aff2 grid.418548.40000000404801120Pathology & Laboratory MedicineCalgary Laboratory Services Calgary Alberta Canada
- Simon Travis
- Kennedy Institute and Translational Gastroenterology Unit, University of Oxford and Biomedical Research Centre, Oxford, UK
- Dhiraj Tripathi
- Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Sue Jowett
- Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
- Gemma Slinn
- Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK
- Steven Masson
- Liver unit, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK
- Andrew King
- Manchester Centre for Clinical Neurosciences, Salford Royal Hospitals NHS Trust, Salford, UK
- Imran Patanwala
- Liverpool University Hospitals Nhs Foundation Trust, Liverpool, UK
- Ameet Dhar
- Ruairi Lynch
- 1Queen’s Medical Research Institute, University of Edinburgh, Edinburgh, UK
- Adrian Stanley
- Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK
- Hamish Ireland
- 1Royal Infirmary Edinburgh, Edinburgh, UK
- Peter Hayes
- The Liver Unit, Royal Infirmary of Edinburgh, Edinburgh, UK
- Robert Driver
- 1University of Leeds, Leeds, UK
- Laura Harrison
- University Hospital Bristol and Weston NHS Foundation Trust, Bristol, UK
- Tom Pembroke
- Welsh trainees research network collaborative, UK
- David Patch
- Hepatology and Liver Transplantation, Royal Free Hampstead NHS Trust, London, UK
- Dominic Yu
- 2 Department of Radiology, Royal Free London NHS Foundation Trust, London, UK
- Janisha Patel
- 1 Department of Hepatology, University Hospital Southampton NHS Foundation Trust, Southampton, Southampton, UK
- James Maurice
- Gastroenterology and hepatology, North Bristol NHS Trust, Westbury on Trym, UK
- Matthew Armstrong
- National Institute for Health Research (NIHR) Biomedical Research Centre Birmingham, University of Birmingham, Birmingham, UK
- Joanna Leithead
- 8 Department of Hepatology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
- Matthew J Armstrong
- Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, UK
- Nicholas Roslund
- 10 Patient Representative, London, UK
- Mandy Lomax
- Walton on Thames, UK
- Homoyon Mehrzad
- Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Richard J Aspinall
- Gastroenterology and Hepatology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK
- Teik Choon See
- 2 Department of Radiology, Addenbrooke`s Hospital, Cambridge, UK
- Fidan Yousuf
- Gwent Liver Unit, Aneurin Bevan University Healthboard, Newport, UK
- Naaventhan Palaniyappan
- NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK
- Elizabeth Brettell
- 2 Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Jeremy Cobbold
- Roger McCorry
- Royal Victoria Hospital, Belfast, UK
- Emily Lam
- 1Enara Bio Ltd, Oxford, Oxfordshire, UK
- Jayshri Shah
- William Harvey Hospital, EKHUFT, Ashford, UK, Introduction
- Evangelia Fatourou
- 1Sheila Sherlock Liver Centre and UCL Institute for Liver and Digestive Health, Royal Free Hospital, London, UK
- Edward Britton
- Marie Curie Hospice Liverpool, Liverpool University Foundation Trust
- Jude Morris
- NHS Greater Glasgow and Clyde, UK
- Catherine Moakes
- Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK
- Alisha Maher
- Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK
- Sukhwant Sehmi
- Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK
- Syed Alam
- Victoria J Appleby
- Jagadish Nagaraj
- DOI
- https://doi.org/10.1136/bmjgast-2023-001314
- Journal volume & issue
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Vol. 11,
no. 1
Abstract
Introduction In liver cirrhosis, acute variceal bleeding (AVB) is associated with a 1-year mortality rate of up to 40%. Data on early or pre-emptive transjugular intrahepatic portosystemic stent–shunt (TIPSS) in AVB is inconclusive and may not reflect current management strategies. Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in AVB (REACT-AVB) aims to investigate the clinical and cost-effectiveness of early TIPSS in patients with cirrhosis and AVB after initial bleeding control.Methods and analysis REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7–13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK.Ethics and dissemination Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication.Trial registration number ISRCTN85274829; protocol version 3.0, 1 July 2023.
