NCT02364297

TIPS in Fundal Variceal Bleeding (the TFB Study)

Efficacy of Early-TIPS in the Treatment of Acute Variceal Bleeding From Gastric Fundal Varices: a RCT vs Standard Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In the last years, important advances have been done in the treatment and prevention of fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic therapy (with tissue adhesives) should be the first line therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal variceal bleeding showed that an early TIPS, performed during the first 72h after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. Moreover, survival was also significantly increased as well as other portal-hypertension related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, etc). The present study is directed at comparing the outcome of patients with acute bleeding from fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic injection of tissue adhesives) with or without early TIPS (performed during the first 1-5 days after admission). Main end-point will be survival free of variceal rebleeding at 1 year from inclusion.

Conditions

• Portal Hypertension
• Bleeding Gastric Varices

Interventions

Type	Name	Description
DEVICE	Early TIPS	TIPS (first 5 days)

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2015-02-18
• Last updated: 2018-03-15

Locations

5 sites across 1 country: Spain