Contact information
Type
Scientific
Primary contact
Prof Tilman Sauerbruch
ORCID ID
Contact details
Sigmund-Freud-Str. 25
Bonn
53105
Germany
+49 (0)228 287 5216
sauerbruch@uni-bonn.de
Additional identifiers
EudraCT number
2005-003557-27
ClinicalTrials.gov number
Protocol/serial number
SA-388-4-1
Study information
Scientific title
Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis
Acronym
Study hypothesis
The objective of this trial is to show that an intrahepatic shunt by insertion of a small-diameter polytetrafluoroethylene (PTFE) covered stent (cTIPS) is the superior method for secondary prevention of variceal bleeding in cirrhosis when compared to an optimised standard treatment that includes hemodynamically monitored drug treatment (propranolol and isosorbide-5-mononitrate [IsMn]) or endoscopic banding ligation in haemodynamic non-responders.
Ethics approval
Ethics Committee of the University of Bonn, 23/01/2006, ref: 110/05
Study design
Randomised controlled open multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Liver cirrhosis
Intervention
PTFE-coated TIPS versus optimized medical treatment including drug treatment with propanolol and isosorbide-5-mononitrate with or without ligation
Intervention type
Drug
Phase
Not Applicable
Drug names
Propanolol, isosorbide-5-mononitrate
Primary outcome measure
Re-bleeding incidence
Secondary outcome measures
1. Overall survival
2. Safety
3. Quality of life
4. Direct and indirect costs
Overall trial start date
01/03/2006
Overall trial end date
01/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Liver cirrhosis (histological or clinical diagnosis)
2. Child-Pugh score less than 12
3. Serum bilirubin less than 3 mg/dl
4. Significant variceal bleeding greater than 5 days prior to randomisation
5. Clinical indication for re-bleeding prophylaxis (i.e. presence of esophageal varices greater than or equal to grade 2)
6. Age 18 to 75
7. Written informed consent signed and dated by patient and investigator
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
186 (93 per group)
Participant exclusion criteria
1. Overt hepatic encephalopathy independent from bleeding
2. Pre-hepatic portal hypertension
3. Type II gastric varices as exclusive bleeding site
4. Established chronic drug treatment with beta-blockers and/or nitrates against portal hypertension
5. Listing for liver transplantation on T2 status
6. Existing porto-systemic shunt (TIPS or surgical shunt)
7. Heart failure according to the New York Heart Association (NYHA) classification greater than 2 or ejection fraction less than 40%
8. Contraindication against propanolol or nitrates
9. Platelet count less than 30 g/l, prothrombin index less than 30%, disseminated intravascular coagulation
10. Advanced malignancy or severe infection
11. Females of child bearing potential not using a safe contraceptive measure during the study or females with a positive pregnancy test prior to study or nursing women
Recruitment start date
01/03/2006
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Sigmund-Freud-Str. 25
Bonn
53105
Germany
Sponsor information
Organisation
Individual sponsor (Germany)
Sponsor details
Prof Dr Büttner
Dean of the Medical Faculty
University of Bonn
Sigmund-Freud-Str. 25
Bonn
53127
Germany
+49 (0)228 287 9200
med-deka@ukb.uni-bonn.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
Deutsche Forschungsgemeinschaft (ref: DFG-AZ 60665-02-2/401/04)
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
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
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25989386