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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21706
Enrollment
72
Registered
2007-05-16
Start date
2007-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TIPS, endoscopic treatment, variceal bleeding (TIPS, endoscopische behandeling, varices bloedingen)

Interventions

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.

Sponsors

Erasmus MC, department of Radiology and Department of Gastro-enterology
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Secondary

MeasureTime frame
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

Primary

MeasureTime frame
Recurrence of variceal bleeding

Contacts

Public ContactE.J. Kuipers

Erasmus MC, University Medical Center Rotterdam Department of Gastroenterology and Hepatology

e.j.kuipers@erasmusmc.nl+31 (0)10 4634681

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)