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Clinical Trials/NL-OMON21706
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

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

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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