Portal Hypertension Clinical Trial
— TFBOfficial title:
Efficacy of Early-TIPS in the Treatment of Acute Variceal Bleeding From Gastric Fundal Varices: a RCT vs Standard Therapy
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.
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. |
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 |
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 |
Spain,
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
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 |
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