NCT02364297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

February 5, 2015

Last Update Submit

March 13, 2018

Conditions

Portal HypertensionBleeding Gastric Varices

Keywords

Bleeding gastric varicesTransjugular intrahepatic portosystemic shunt (TIPS)Injection of adhesives

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Absence of portal hypertension-related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome)

    6 weeks and 1 year

  • Transfusional requirements

    6 weeks and 1 year

  • Individual adverse events

    1 year

  • Hospital stay

    1 year

  • Use of hospital resources

    1 year

Study Arms (2)

Early TIPS

ACTIVE COMPARATOR

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.

Device: Early TIPS

Control

PLACEBO COMPARATOR

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).

Device: Early TIPS

Interventions

Early TIPSDEVICE

TIPS (first 5 days)

ControlEarly TIPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • Terminal liver disease (bilirrubin \> 10 mg/dL and/or prothrombin index \< 30%); or other fatal non-liver diseases.
  • Denied informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Germans Trias i Pujol

Badalona, Catalonia, Spain

RECRUITING

ICU Liver Unit. Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

RECRUITING

Hospital del Mar

Barcelona, Catalonia, Spain

RECRUITING

Hospital Arnau de Vilanova

Lleida, Spain

RECRUITING

Related Publications (3)

  • 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.

    PMID: 17879356BACKGROUND

  • 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.

    PMID: 18435460BACKGROUND

  • 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.

    PMID: 20573925RESULT

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Angels Escorsell, MD

    Senior Consultant. Liver Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angels Escorsell, MD

CONTACT

34932275400aescor@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 18, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

ES(5)