학술논문
Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent–shunt in Acute Variceal Bleeding (REACT-AVB trial)
Document Type
article
Author
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
Source
BMJ Open Gastroenterology, Vol 11, Iss 1 (2024)
Subject
Language
English
ISSN
2054-4774
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.