No registrations found.
ID
Source
Brief title
Health condition
TIPS, endoscopic treatment, variceal bleeding
(TIPS, endoscopische behandeling, varices bloedingen)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence of variceal bleeding
Secondary outcome
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
Background summary
Patients 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.
Study objective
TIPS 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.
Study design
-
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 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.
Department of Gastroenterology and Hepatology<br>
E.J. Kuipers
’s-Gravendijkwal 230
Rotterdam 3015 C
The Netherlands
+31 (0)10 4634681
e.j.kuipers@erasmusmc.nl
Department of Gastroenterology and Hepatology<br>
E.J. Kuipers
’s-Gravendijkwal 230
Rotterdam 3015 C
The Netherlands
+31 (0)10 4634681
e.j.kuipers@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL948 |
| NTR-old | NTR973 |
| Other | - : - |
| ISRCTN | ISRCTN77521636 |