Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis
| ISRCTN | ISRCTN16334693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16334693 |
| EudraCT/CTIS number | 2005-003557-27 |
| Secondary identifying numbers | SA-388-4-1 |
- Submission date
- 26/01/2006
- Registration date
- 22/03/2006
- Last edited
- 15/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Tilman Sauerbruch
Scientific
Scientific
Sigmund-Freud-Str. 25
Bonn
53105
Germany
| Phone | +49 (0)228 287 5216 |
|---|---|
| sauerbruch@uni-bonn.de |
Study information
| Study design | Randomised controlled open multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Covered transjugular intrahepatic portosystemic stent shunt versus optimised medical treatment for the secondary prevention of variceal bleeding in cirrhosis |
| Study objectives | 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(s) | Ethics Committee of the University of Bonn, 23/01/2006, ref: 110/05 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2006 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 186 (93 per group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Sigmund-Freud-Str. 25
Bonn
53105
Germany
53105
Germany
Sponsor information
Individual sponsor (Germany)
Research organisation
Research organisation
Prof Dr Büttner
Dean of the Medical Faculty
University of Bonn
Sigmund-Freud-Str. 25
Bonn
53127
Germany
| Phone | +49 (0)228 287 9200 |
|---|---|
| med-deka@ukb.uni-bonn.de |
Funders
Funder type
Research council
Deutsche Forschungsgemeinschaft (ref: DFG-AZ 60665-02-2/401/04)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2015 | Yes | No |
Editorial Notes
15/06/2017: Publication reference added.
