TIPS in Fundal Variceal Bleeding (the TFB Study)

NCT ID: NCT02364297

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

Portal Hypertension; Bleeding Gastric Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early TIPS

Intervention Type: DEVICE

TIPS (first 5 days)

Control

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).

Group Type: PLACEBO_COMPARATOR

Early TIPS

Intervention Type: DEVICE

TIPS (first 5 days)

Interventions

Early TIPS

TIPS (first 5 days)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

Hospital del Mar

OTHER

Sponsor Role: collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: lead

Responsible Party

Àngels Escorsell

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angels Escorsell, MD

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant. Liver Unit

Locations

Hospital Germans Trias i Pujol

Badalona, Catalonia, Spain

Site Status: RECRUITING

ICU Liver Unit. Hospital Clinic of Barcelona

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Hospital Arnau de Vilanova

Lleida, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Angels Escorsell, MD

Role: CONTACT

aescor@clinic.cat

34932275400 ext. 4030

Facility Contacts

Rosa Morillas, MD

Role: primary

Angels Escorsell, MD

Role: primary

aescor@clinic.cat

34932275400 ext. 4030

Càndid Villanueva, MD

Role: primary

cvillanueva@santpau.cat

José Carrión, MD

Role: primary

Carles Aracil, MD

Role: primary

carbla34@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 17879356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18435460 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20573925 (View on PubMed)

Other Identifiers

PI 14/00392

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ET_GV15

Identifier Type: -

Identifier Source: org_study_id