Contact information
Type
Scientific
Primary contact
Dr F.H.D. Sebus
ORCID ID
Contact details
Erasmus Medical Centre
Department of Radiology
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 4632277
f.sebus@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Transjugular Intrahepatic Porto-systemic Shunt (TIPS) using covered stents will be equally or more effective, cost-effective and safe as/safer than endoscopic treatment in the secondary prevention of gastro-oesophageal variceal bleeding.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, multicentre, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Gastro-oesophageal variceal bleeding
Intervention
Transjugular Intrahepatic Porto-systemic Shunt (TIPS)(intervention group):
A shunt is made between the portal vein and the systemic veins, which decreases blood pressure in the portal vein to normal. This decreases the risk of re-bleeding. The procedure takes approximately two hours.
Endoscopic treatment (control group):
The bleeding varices are ligated or sclerosed. The pressure in the portal vein remains too high. This procedure has to be repeated several times until the varices are completely obliterated.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Recurrence of variceal bleeding
Secondary outcome measures
1. Occurrence of treatment failure (either switch to other therapy -cross-over- or death)
2. Incidence of encephalopathy, defined as occurrence of grade II, III or IV encephalopathy
3. Liver function (according to Child-Pugh class)
4. Mortality
5. Quality of life
6. Costs
Overall trial start date
01/06/2007
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients presenting with a first or second episode of oesophageal or gastric variceal bleeding, as documented by endoscopy and meeting accepted diagnostic criteria
2. Initial stabilisation (absence of evidence of continued bleeding)
3. Informed consent
4. Aged more than 18 and less than 76 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
124
Participant exclusion criteria
1. History of serious or refractory encephalopathy, unrelated to gastrointestinal bleeding
2. History of significant heart failure (New York Heart Association [NYHA] class III & IV)
3. Portal hypertension due to other causes than liver disease (e.g. portal vein or splenic vein thrombosis)
4. Previous TIPS placement
5. Advanced hepatocellular carcinoma
6. Severely compromised liver function (Child-Pugh score greater than 13)
7. Sepsis and/or multiorgan failure
Recruitment start date
01/06/2007
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Radiology
Dr. Molewaterplein 50
Rotterdam
3015 GE
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.erasmusmc.nl/content/englishindex.htm#http://www.erasmusmc.nl/content/englishindex.htm
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary