Bleeding Gastric Varices, Portal Hypertension
Conditions
Keywords
Bleeding gastric varices, Transjugular intrahepatic portosystemic shunt (TIPS), Injection of adhesives
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.
Interventions
DEVICEEarly TIPS
TIPS (first 5 days)
Sponsors
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital Universitario Ramon y Cajal
Hospital del Mar
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Spain
Contacts
Primary ContactAngels Escorsell, MD
Outcome results
None listed