A controlled clinical trial investigating the clinical and cost-effectiveness of early Transjugular Intrahepatic Portosystemic Stent-Shunt (TIPSS) procedure to insert a stent (tube) in the liver to reduce pressure versus endoscopic plus drug therapy in patients with cirrhosis and acute variceal bleeding after initial control of bleeding by variceal band ligation (VBL)

Not Applicable

• Conditions: Complications of cirrhosis; Digestive System

• Registration Number: ISRCTN85274829
• Lead Sponsor: niversity of Birmingham

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjgast-2023-001314 (added 25/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-30
• Last Update Posted: 8 April 2024
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

1. Liver cirrhosis as defined clinically, radiologically (ultrasound scan (USS) and/or 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 years

Exclusion Criteria

1. Failure to control acute bleeding (as per Baveno 7 criteria) 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. Clinically significant encephalopathy causing recurrent hospital admissions.
6. Pregnant or lactating women.
7. Evidence of heart failure refractory to treatment.
8. Severe active septicaemia refractory to treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified