Status:
TERMINATED
Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of compl...
Detailed Description
Clinical Efficacy of Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents in Cirrhotic Patients: A Randomized Controlled Study Introduction In the treatment of esophageal va...
Eligibility Criteria
Inclusion
- All consecutive cirrhotic patients who have undergone TIPS at our Department for bleeding of esophagogastric varices refractory to medical or endoscopic treatment or for ascites/hydrothorax refractory to diuretic therapy will be considered eligible for the study.
Exclusion
- an age \>75 years; past or present history of hepatic encephalopathy;
- a Z-score at trial making test-A (TMT-A) \>1.5;
- bilirubine levels \>5 mg/dl;
- creatinine levels \>3 mg/dl;
- serious cardiac or pulmonary dysfunction;
- a Child-Pugh's score \>11;
- a model end-stage liver disease (MELD) score \>18;
- portal thrombosis;
- a diagnosis of hepatic carcinoma;
- sepsis;
- spontaneous bacterial peritonitis;
- renal insufficiency.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00401895
Start Date
January 1 2006
End Date
December 1 2008
Last Update
January 9 2009
Active Locations (1)
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1
Gastroenterology Unit. dip. Medicina Clinica Policlinico Umberto I
Roma, Italy, 00100