Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex® covered stent-graft versus endoscopic treatment for secondary prevention of gastro-oesophageal variceal bleeding
| ISRCTN | ISRCTN77521636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77521636 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 21/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.H.D. Sebus
Scientific
Scientific
Erasmus Medical Centre
Department of Radiology
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Phone | +31 (0)10 4632277 |
|---|---|
| f.sebus@erasmusmc.nl |
Study information
| Study design | Randomised, multicentre, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2007 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3015 CE
Netherlands
3015 CE
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Radiology
Dr. Molewaterplein 50
Rotterdam
3015 GE
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm#http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
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 |
