NL-OMON21706
Not yet recruiting
Not Applicable
Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex(R) covered stent-graft versus endoscopic treatment for secondary prevention of gastro-esophageal variceal bleeding.
Erasmus MC, department of Radiology and Department of Gastro-enterology0 sites72 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- TIPS, endoscopic treatment, variceal bleeding(TIPS, endoscopische behandeling, varices bloedingen)
- Sponsor
- Erasmus MC, department of Radiology and Department of Gastro-enterology
- Enrollment
- 72
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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