At a glance
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Early Use of Transjugular Intrahepatic Portosystemic Shunt (TIPSS) in Patients With Cirrhosis and Variceal Bleeding
In Brief
A clinical study evaluating Endoscopic Variceal Band Ligation and Transjugular Intrahepatic Porto-Systemic Stent Shunt for Liver Cirrhosis and Variceal Haemorrhage. Completed, enrolled 59 participants across 2 sites.
Detailed Summary
Gastro-oesophageal varices (swollen veins in the gullet and stomach) are present in 50% of patients with liver cirrhosis and are its most serious complication as their rupture results in potentially life threatening bleeding. Bleeding from these veins occurs in up to one third of patients with varices. This is associated with 20% mortality at 6 weeks. In the event of bleeding from these veins the current UK guidelines recommend certain drugs followed by early endoscopic treatment with variceal band ligation (rubber bands placed over the veins to stop them bleeding). The use of a shunt inside the liver ("TIPSS" transjugular intrahepatic portosystemic shunt) is largely reserved for cases of uncontrolled bleeding from these swollen veins. A recent randomised multicenter study carried out by Garcia Pagan and colleagues reported improved survival with early TIPSS in patients with bleeding from these swollen veins in advanced liver disease. From these guideline international guidelines now recommend consideration of early TIPSS for all high-risk patients presenting with variceal bleeding. This practice clearly has significant cost implications. To validate the findings a further randomised control trial is needed. This is a multi-center parallel-group randomized controlled trial. Both hospitals taking part in the trial will have a TIPSS service. Patients who consent to enter the trial will be randomized to either: (1) Endoscopic treatment (standard care) or (2) early TIPSS. Potential participants will be all patients with a diagnosis of liver cirrhosis presenting with an acute variceal bleed to a participating hospital who do not fulfill an exclusion criteria. All causes of cirrhosis will be included. Participants will be reviewed during their regular hepatology clinic appointments at their respective hospitals on 3 occasions over a one-year period.
Study Details
Timeline
Interventions
Standard care: Endoscopic application of rubber bands to varices (swollen veins) in the oesophagus this is repeated on 4-5 occasions until the varices are eradicated.
Within 72 hours of the initial endoscopy to apply bands to the bleeding varices the patient undergoes a Transjugular Intrahepatic Porto-Systemic Stent Shunt (TIPSS) procedure. Under x-ray guidance a shunt is created in the liver between the hepatic vein and portal vein via a catheter introduced via the jugular vein. It may require a check once or twice per year to ensure it remains patent.