TIPS in Fundal Variceal Bleeding (the TFB Study)

Not Applicable

• Conditions: Bleeding Gastric Varices; Portal Hypertension
• Interventions: Device: Early TIPS

• Registration Number: NCT02364297
• Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Study Start: 2015-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients developing acute variceal bleeding from GOV2 and/or IGV1 defined according to Baveno II criteria, admitted in the Hospital and receiving standard combined medical therapy (somatostatin 3 mg/12h continuous IV infusion or terlipressin, 2mg/4h IV + endoscopic injection of tissue adhesives as per center protocol).

Exclusion Criteria

• Hepatocarcinoma without therapeutic options (according to Milan criteria).
• Portal or mesenteric vein thrombosis avoiding the performance of TIPS.
• Acute alcoholic hepatitis.
• Platelet count < 20.000/mm3.
• Previous treatment with portosystemic shunt.
• Pregnancy.
• Previous inclusion in the current study.
• Terminal liver disease (bilirrubin > 10 mg/dL and/or prothrombin index < 30%); or other fatal non-liver diseases.
• Denied informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early TIPS	Early TIPS	Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic injection of tissue adhesives according to the center protocol. Performance of TIPS in the first 5 days following acute gastric variceal bleeding.
Control	Early TIPS	Standard treatment to achieve initial hemostasis: vasoactive drugs (somatostatin or terlipressin) + endoscopic injection of tissue adhesives according to the center protocol. Standard combined endoscopic and pharmacological therapy as a secondary prophylaxis (beta-blockers or carvedilol + repeated injection of tissue adhesives until the erradication of the fundal varices).

Primary Outcome Measures

Name	Time	Method
Combined: Absence of rebleeding + survival	1 year	The primary endpoint combines absence of rebleeding + survival during the first 1 year after inclusion in the study. Patients to compare are those with liver cirrhosis and acute bleeding from IGV1 or GOV2 varices initially treated with combined pharmacological and endoscopic therapy. Those patients will be randomized to receive a TIPS or standard medical therapy (pharmacological + endoscopic injection of tissue adhesives)

Secondary Outcome Measures

Name	Time	Method
Absence of portal hypertension-related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome)	6 weeks and 1 year	Comparison of the development of portal-hypertension related complications.
Transfusional requirements	6 weeks and 1 year	We will compare the number of packed red blood cells required by each treatment arms as a surrogate of rebleeding.
Individual adverse events	1 year	Related and not related to the therapies under study.
Hospital stay	1 year	Including the stay for the index bleed and also readmissions due to complications of liver disease.
Use of hospital resources	1 year	Use of hospital resources other than specified in the treatment arms (TIPS, revision of TIPS patency, derivative surgery or additional endoscopic therapy).

Trial Locations

Locations (5)

ICU Liver Unit. Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Catalonia, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital del Mar; 🇪🇸 Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain