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Trial record 8 of 9 for:    "Esophageal Disease" | "Terlipressin"

TIPS in Fundal Variceal Bleeding (the TFB Study) (TFB)

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ClinicalTrials.gov Identifier: NCT02364297
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Àngels Escorsell, Institut d'Investigacions Biomèdiques August Pi i Sunyer

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.


Condition or disease Intervention/treatment Phase
Portal Hypertension Bleeding Gastric Varices Device: Early TIPS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Early-TIPS in the Treatment of Acute Variceal Bleeding From Gastric Fundal Varices: a RCT vs Standard Therapy
Study Start Date : September 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Device: Early TIPS
TIPS (first 5 days)

Placebo Comparator: 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).

Device: Early TIPS
TIPS (first 5 days)




Primary Outcome Measures :
  1. Combined: Absence of rebleeding + survival [ Time Frame: 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 Outcome Measures :
  1. Absence of portal hypertension-related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome) [ Time Frame: 6 weeks and 1 year ]
    Comparison of the development of portal-hypertension related complications.

  2. Transfusional requirements [ Time Frame: 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.

  3. Individual adverse events [ Time Frame: 1 year ]
    Related and not related to the therapies under study.

  4. Hospital stay [ Time Frame: 1 year ]
    Including the stay for the index bleed and also readmissions due to complications of liver disease.

  5. Use of hospital resources [ Time Frame: 1 year ]
    Use of hospital resources other than specified in the treatment arms (TIPS, revision of TIPS patency, derivative surgery or additional endoscopic therapy).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364297


Contacts
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Contact: Angels Escorsell, MD 34932275400 ext 4030 aescor@clinic.cat

Locations
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Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Catalonia, Spain
Contact: Rosa Morillas, MD         
ICU Liver Unit. Hospital Clinic of Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Angels Escorsell, MD    34932275400 ext 4030    aescor@clinic.cat   
Principal Investigator: Angels Escorsell, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Catalonia, Spain
Contact: Càndid Villanueva, MD       cvillanueva@santpau.cat   
Hospital del Mar Recruiting
Barcelona, Catalonia, Spain
Contact: José Carrión, MD         
Hospital Arnau de Vilanova Recruiting
Lleida, Spain
Contact: Carles Aracil, MD       carbla34@gmail.com   
Sponsors and Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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
Investigators
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Principal Investigator: Angels Escorsell, MD Senior Consultant. Liver Unit

Publications of Results:
Other Publications:
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Responsible Party: Àngels Escorsell, Senior Consultant, Institut d'Investigacions Biomèdiques August Pi i Sunyer
ClinicalTrials.gov Identifier: NCT02364297     History of Changes
Other Study ID Numbers: ET_GV15
PI 14/00392 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Keywords provided by Àngels Escorsell, Institut d'Investigacions Biomèdiques August Pi i Sunyer:
Bleeding gastric varices
Transjugular intrahepatic portosystemic shunt (TIPS)
Injection of adhesives
Additional relevant MeSH terms:
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Hypertension, Portal
Esophageal and Gastric Varices
Hemorrhage
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases