REACT-AVB
Research type
Research Study
Full title
Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB)
IRAS ID
314108
Contact name
Dhiraj Tripathi
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 11 months, 30 days
Research summary
Cirrhosis (scarring of the liver) can lead to varices (abnormally enlarged veins) developing in the lower gullet (food pipe) or stomach causing the varices to bleed. Variceal bleeding is a serious complication of liver cirrhosis.
The currently accepted treatment for patients who bleed from varices is known as standard of care (SOC) and includes using an endoscope (a bendy tube incorporating light and a tiny video camera) to tie off an enlarged vein with a rubber ring (variceal banding) or injecting a drug, with a needle, directly into the swollen vein, causing the vein to clot and stop the bleeding. Patients may also be prescribed antibiotics and other drugs like beta-blockers to lower pressure in the enlarged veins to reduce the risk of further bleeding
For some patients, a device called a Transjugular Intrahepatic Portosystemic Stent-Shunt (TIPSS) is used. The TIPSS procedure involves placing a special small metal tube, roughly 10mm in diameter, inside the liver using a wire passed through a vein in the neck and down through the liver. The procedure is done under sedation or general anaesthetic. TIPSS may be used to treat severe variceal bleeding in an emergency to stop bleeding where SOC has not worked or patients that are at high risk of bleeding again after satisfactory stabilisation with SOC. This is called “early” TIPSS.
The REACT-AVB trial will compare “early” TIPSS with SOC in severe variceal bleeding patients to see if “early” TIPSS treatment is better than SOC in improving the survival of the patients. It will also compare cost-effectiveness and quality of life for the patients for both treatments.
REACT-AVB will be recruiting patients from hospitals throughout the UK and the trial will last 72 months.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0085
Date of REC Opinion
4 Jul 2023
REC opinion
Further Information Favourable Opinion