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Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex(R) covered stent-graft versus endoscopic treatment for secondary prevention of gastro-esophageal variceal bleeding.


- candidate number2584
- NTR NumberNTR973
- ISRCTNISRCTN77521636
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR16-mei-2007
- Secondary IDs 
- Public TitleTransjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex(R) covered stent-graft versus endoscopic treatment for secondary prevention of gastro-esophageal variceal bleeding.
- Scientific TitleTransjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex(R) covered stent-graft versus endoscopic treatment for secondary prevention of gastro-esophageal variceal bleeding.
- ACRONYMTIPS TRUE
- hypothesisTIPS using covered stents will be equally or more effective, cost-effective and safe as/than endoscopic treatment in the secondary prevention of gastro-esophageal variceal bleeding.
- Healt Condition(s) or Problem(s) studiedTransjugular intrahepatic portosystemic shunt (TIPS), Endoscopic treatment, Variceal bleeding, Transjugular intrahepatic portosystemic shunt (TIPS)
- Inclusion criteria1. Patients presenting with a first or second episode of esophageal or gastric variceal bleeding, as documented by endoscopy and meeting accepted diagnostic criteria; 2. Initial stabilization (absence of evidence of continued bleeding); 3. Informed consent; 4. Age > 18 and < 76 years
- Exclusion criteria1. History of serious or refractory encephalopathy, unrelated to gastrointestinal bleeding; 2. History of significant heart failure (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 >13); 7. Sepsis and/or multiorgan failure
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jun-2007
- planned closingdate1-jun-2009
- Target number of participants124
- InterventionsTransjugular 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 2 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.
- Primary outcomeRecurrence of variceal bleeding
- Secondary outcome1. 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
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. E.J. Kuipers
- CONTACT for SCIENTIFIC QUERIESMD. I.L. Holster
- Sponsor/Initiator Erasmus Medical Center, department of Radiology, Erasmus Medical Center, Department of Hepatology and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryPatients with liver cirrhosis and bleeding from gastro-esophageal varices are currently largely treated with endoscopic (variceal band ligation; tissue glue injection) therapy. When this treatment, the accepted second-line treatment is radiological creation of a Transjugular Intrahepatic Porto-systemic Shunt (TIPS). Previous studies comparing endoscopic therapy with TIPS found that TIPS is more effective in reducing the risk of recurrent variceal bleeding but is associated with a higher risk of hepatic encephalopathy and does not improve survival. Recently, the efficacy of TIPS has been remarkedly improved by using covered stents. These stents significantly decrease the risk of shunt obstruction, which was the main problem with TIPS using conventional, bare stents. Given the probably significantly improved efficacy of TIPS with covered stents, this trial will re-assess the question whether TIPS might be superior (concerning efficacy and cost-effectiveness) to endoscopic procedures when performed early after a first or second episode of gastro-esophageal bleeding.
- Main changes (audit trail)02-Mar-2013: The calculated amount of participants has been adjusted from 124 to 72. Planned closing date will be 01-Jan-2014 - NM
- RECORD15-mei-2007 - 2-mrt-2013


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