Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Early Use of Transjugular Intrahepatic Portosystemic Shunt (TIPSS) in Patients With Cirrhosis and Variceal Bleeding
Brief 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.


Options:
A: Arm Label: Endoscopic Variceal Band Ligation (EVBL); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Endoscopic Variceal Band Ligation | Arm Label: Early TIPSS; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Endoscopic Variceal Band Ligation, Procedure: Transjugular Intrahepatic Porto-Systemic Stent Shunt | Intervention Type: PROCEDURE; Name: Endoscopic Variceal Band Ligation; Assigned to Arm(s): Early TIPSS, Endoscopic Variceal Band Ligation (EVBL) | Intervention Type: PROCEDURE; Name: Transjugular Intrahepatic Porto-Systemic Stent Shunt; Assigned to Arm(s): Early TIPSS
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency portacaval shunt | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Other: Emergency TIPS | Intervention Type: PROCEDURE; Name: Emergency portacaval shunt; Assigned to Arm(s): A | Intervention Type: OTHER; Name: Emergency TIPS; Assigned to Arm(s): B
C: Arm Label: Portacaval shunt; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Portacaval shunt | Arm Label: Sclerotherapy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Sclerotherapy | Intervention Type: PROCEDURE; Name: Portacaval shunt; Assigned to Arm(s): Portacaval shunt | Intervention Type: PROCEDURE; Name: Sclerotherapy; Assigned to Arm(s): Sclerotherapy
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency portacaval shunt | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Emergency and long-term endoscopic sclerotherapy | Intervention Type: PROCEDURE; Name: Emergency portacaval shunt; Assigned to Arm(s): A | Intervention Type: PROCEDURE; Name: Emergency and long-term endoscopic sclerotherapy; Assigned to Arm(s): B

Answer: A