TIPS in Fundal Variceal Bleeding (the TFB Study)

Portal Hypertension Clinical Trial

— TFB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364297
• Other study ID #: ET_GV15
• Secondary ID: PI 14/00392
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2015
• Last updated: March 13, 2018
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: Angels Escorsell, MD
• Phone: 34932275400
• Email: aescor[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding Gastric Varices
• Esophageal and Gastric Varices
• Hemorrhage
• Hypertension, Portal
• Portal Hypertension

Intervention

Device:
• Early TIPS
TIPS (first 5 days)

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Catalonia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia
Spain	Hospital del Mar	Barcelona	Catalonia
Spain	ICU Liver Unit. Hospital Clinic of Barcelona	Barcelona	Catalonia
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (6)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital del Mar, Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (3)

García-Pagán JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mössner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and va — View 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. — View 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. Erratum in: Hepatology. 2007 Dec;46(6):2052. — View Citation

Outcome

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