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Early Use of TIPSS in Patients With Cirrhosis and Variceal Bleeding (EarlyTIPSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377141
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:

Gastro-oesophageal varices (swollen veins in the gullet and stomach) are present in 50% of patients with liver cirrhosis and are its most serious complication as their rupture results in potentially life threatening bleeding. Bleeding from these veins occurs in up to one third of patients with varices. This is associated with 20% mortality at 6 weeks.

In the event of bleeding from these veins the current UK guidelines recommend certain drugs followed by early endoscopic treatment with variceal band ligation (rubber bands placed over the veins to stop them bleeding). The use of a shunt inside the liver ("TIPSS" transjugular intrahepatic portosystemic shunt) is largely reserved for cases of uncontrolled bleeding from these swollen veins. A recent randomised multicenter study carried out by Garcia Pagan and colleagues reported improved survival with early TIPSS in patients with bleeding from these swollen veins in advanced liver disease. From these guideline international guidelines now recommend consideration of early TIPSS for all high-risk patients presenting with variceal bleeding. This practice clearly has significant cost implications. To validate the findings a further randomised control trial is needed.

This is a multi-center parallel-group randomized controlled trial. Both hospitals taking part in the trial will have a TIPSS service. Patients who consent to enter the trial will be randomized to either: (1) Endoscopic treatment (standard care) or (2) early TIPSS.

Potential participants will be all patients with a diagnosis of liver cirrhosis presenting with an acute variceal bleed to a participating hospital who do not fulfill an exclusion criteria. All causes of cirrhosis will be included.

Participants will be reviewed during their regular hepatology clinic appointments at their respective hospitals on 3 occasions over a one-year period.


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Variceal Haemorrhage Procedure: Endoscopic Variceal Band Ligation Procedure: Transjugular Intrahepatic Porto-Systemic Stent Shunt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Use of Transjugular Intrahepatic Portosystemic Shunt (TIPSS) in Patients With Cirrhosis and Variceal Bleeding
Actual Study Start Date : April 18, 2011
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endoscopic Variceal Band Ligation (EVBL)
Participants in this group will receive standard medical care consisting of vasoactive drugs (Terlipressin 2mg QDS (where there are no contraindications e.g. severe ischaemic heart disease), antibiotics, and entry into a variceal banding programme (in-patient or out-patient).
Procedure: Endoscopic Variceal Band Ligation
Standard care: Endoscopic application of rubber bands to varices (swollen veins) in the oesophagus this is repeated on 4-5 occasions until the varices are eradicated.
Other Names:
  • Endosopic banding,
  • Banding

Active Comparator: Early TIPSS
For those randomized to early TIPSS the Transjugular Intrahepatic Porto-Systemic Stent Shunt (TIPSS) procedure will be performed within 72 hours (and preferably within the first 24 hours) after initial endoscopy. Vasoactive drugs will be continued until the TIPSS is performed and antibiotics continued for 5-7 days.
Procedure: Endoscopic Variceal Band Ligation
Standard care: Endoscopic application of rubber bands to varices (swollen veins) in the oesophagus this is repeated on 4-5 occasions until the varices are eradicated.
Other Names:
  • Endosopic banding,
  • Banding

Procedure: Transjugular Intrahepatic Porto-Systemic Stent Shunt
Within 72 hours of the initial endoscopy to apply bands to the bleeding varices the patient undergoes a Transjugular Intrahepatic Porto-Systemic Stent Shunt (TIPSS) procedure. Under x-ray guidance a shunt is created in the liver between the hepatic vein and portal vein via a catheter introduced via the jugular vein. It may require a check once or twice per year to ensure it remains patent.
Other Names:
  • TIPSS
  • TIPS




Primary Outcome Measures :
  1. Survival [ Time Frame: One Year ]
    Patient survival at 1 year


Secondary Outcome Measures :
  1. Survival [ Time Frame: 6 weeks ]
    Patient survival at 6 weeks

  2. Liver Transplant-free survival [ Time Frame: To liver transplant (time not defined) ]
    For patients eligible for a liver transplant the time from study entry to transplantation will be noted.

  3. Rate of early re-bleeding [ Time Frame: Within 6 weeks ]
    Recurrent bleeding from oesophageal varices

  4. Rate of late re-bleeding [ Time Frame: 6 weeks to 1 year ]
    Recurrent bleeding from oesophageal varices

  5. The development of hepatic encephalopathy [ Time Frame: Anytime within the year ]
    Time to development of hepatic encephalopathy



Information from the National Library of Medicine

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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:

  • An acute oesophageal variceal bleed with haemostasis following initial endoscopy.
  • A diagnosis of liver cirrhosis
  • Childs-Pugh score ≥8

Exclusion Criteria:

  • Inability to control bleeding at index endoscopy (this is a "rescue TIPSS")
  • Previous portosystemic shunt or TIPSS
  • Bleeding from isolated gastric or ectopic varices
  • Known portal vein thrombosis precluding TIPSS
  • Active cancer including hepatocellular carcinoma
  • Age less than 18 or more than 75
  • Clinically significant encephalopathy causing recurrent hospital admissions
  • Pregnant at time of index endoscopy

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): NCT02377141


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Study Chair: Peter C Hayes, MD PhD University of Edinburgh
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02377141    
Other Study ID Numbers: IRAS 81135
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by University of Edinburgh:
Oesophageal Variceal Bleed
TIPSS
Endoscopic Variceal Band Ligation
Decompensated Liver Disease
Additional relevant MeSH terms:
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Liver Cirrhosis
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases