A large UK trial will test whether inserting a stent-shunt into the liver within four days of a bleeding episode saves more lives than standard treatment for patients with cirrhosis. The problem is acute variceal bleeding—a life-threatening complication of cirrhosis where veins in the oesophagus or stomach rupture. Current standard care (endoscopic therapy plus beta-blockers) stops the bleeding initially, but many patients rebleed or die within a year. An early transjugular intrahepatic portosystemic stent-shunt (TIPSS) reroutes blood flow around the scarred liver, reducing pressure on those veins. Smaller studies have suggested it improves survival, but the evidence is not strong enough to change UK guidelines. If early TIPSS proves superior, it could become the new standard of care for eligible patients, directly reducing deaths and the need for liver transplants. The trial will also measure quality of life, rebleeding rates, and cost-effectiveness—data that NHS commissioners need to decide whether to fund the procedure widely. For the 294 participants randomised across at least 30 UK hospitals, the primary outcome is transplant-free survival at one year.
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Research question: Does early transjugular intrahepatic portosystemic stent-shunt (TIPSS) within 4 days of diagnostic endoscopy result in improved transplant free patient survival when compared with standard of care? Design: This is a pragmatic multicentre randomised controlled open-label two arm superiority parallel group trial. Primary outcome: Transplant free survival at one year Secondary outcomes: 1. Transplant free survival at 6 weeks (from randomisation): 2. Rebleeding (from randomisation) a. Early (within 6 weeks) b. Late (6 weeks to 1 year) 3. Adverse events related to treatment (up to 12 months after randomisation): 4. Other complications of cirrhosis: a. New onset ascites b. New onset encephalopathy c. Spontaneous bacterial peritonitis d. Hepatocellular carcinoma 5. Child-Pugh score at 6 and 12 months. 6. MELD score at 6 and 12 months. 7. Health-related quality of life (EQ-5D-5L) at 6 and 12 months. 8. Use of healthcare resources, costs and cost-effectiveness based on cost per Quality-Adjusted Life-Year (QALY) estimated using the EQ-5D-5L and cost per death avoided at one year, and modelled cost per QALY over patient lifetime. 9. Use of alternative therapies (including diuretics and non-selective beta-blockers) Setting: Acute NHS Trusts and Health Boards in the UK that admit and manage patients with acute variceal bleeding. We propose a minimum of 30 sites. Target population: Patient with liver cirrhosis presenting with acute variceal bleeding which has been controlled by current therapy as recommended in the BSG guidelines.(3) Inclusion criteria: 1. Liver cirrhosis as defined clinically, radiologically (USS and transient elastography) or on histology. 2. Acute variceal bleed (oesophageal or gastric) with haemostasis following initial endoscopic therapy. 3. Child-Pugh score 7-13. 4. Age >= 18 Exclusion Criteria: 1. Failure to control acute bleeding (as per Baveno 6 criteria)(5) prior to randomisation 2. Previous portosystemic shunt or TIPSS 3. Known occlusive portal vein thrombosis precluding TIPSS 4. Active cancer including hepatocellular carcinoma affecting 1 year survival 5. Contraindication to non-selective beta blockers such as asthma. 6. Clinically significant encephalopathy causing recurrent hospital admissions 7. Pregnant or lactating women. 8. Evidence of heart failure refractory to treatment. 9. Severe active septicaemia. Health technologies: 1. Early transjugular intrahepatic portosystemic stent-shunt (TIPSS) within 4 days of diagnostic endoscopy. 2. Endoscopic therapy and non-selective beta-blocker (preferably carvedilol 12.5mg/24h). Sample size: 294 participants (1:1 randomisation) required to show improved transplant free survival from 60% to 80% with early TIPSS with 90% power (alpha=0.05), and allowing for 20% attrition. Study duration: 6 months set up, 4 years for recruitment including a 12 month pilot phase, 1 year follow up and 6 months analysis and reporting. Expertise of team Leading clinical experts in the field who have conducted similar research in the past. The Clinical Trials Unit comprises the Director, statistician, and trial coordinators, with links to qualitative researchers and health economists.
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