Clinical trial NCT02364297: TIPS in Fundal Variceal Bleeding (the TFB Study)
Official title: Efficacy of Early-TIPS in the Treatment of Acute Variceal Bleeding From Gastric Fundal Varices: a RCT vs Standard Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Hypertension
Bleeding Gastric Varices
Keywords: Bleeding gastric varices
Transjugular intrahepatic portosystemic shunt (TIPS)
Injection of adhesives
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Germans Trias i Pujol Hospital
name: Hospital Universitario Ramon y Cajal
name: Hospital del Mar
First posted: 2015-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Combined: Absence of rebleeding + survival
timeFrame: 1 year
Secondary outcomes:
measure: Absence of portal hypertension-related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome)
timeFrame: 6 weeks and 1 year
measure: Transfusional requirements
timeFrame: 6 weeks and 1 year
measure: Individual adverse events
timeFrame: 1 year
measure: Hospital stay
timeFrame: 1 year
measure: Use of hospital resources
timeFrame: 1 year
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalonia
city: Barcelona
country: Spain
facility: ICU Liver Unit. Hospital Clinic of Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Senior Consultant. Liver Unit
name: Angels Escorsell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
citation: Garcia-Tsao G, Bosch J, Groszmann RJ. Portal hypertension and variceal bleeding--unresolved issues. Summary of an American Association for the study of liver diseases and European Association for the study of the liver single-topic conference. Hepatology. 2008 May;47(5):1764-72. doi: 10.1002/hep.22273. No abstract available.
citation: Garcia-Pagan JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mossner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. doi: 10.1056/NEJMoa0910102.