TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
Not Applicable
Completed
- Conditions
- Decompensated CirrhosisPortal HypertensionBleeding Varices
- Registration Number
- NCT01410591
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- Cirrhotic patients with at least one episode of variceal bleeding
- No active bleeding within 5 days before TIPS
- Child-Pugh score ≤13
- Signed written informed consent
Exclusion Criteria
- An age <18 years or >75 years
- With TIPS contraindications
- Past or present history of hepatic encephalopathy
- Pregnancy or breast-feeding
- Hepatic carcinoma and/or other malignancy diseases
- Sepsis
- Spontaneous bacterial peritonitis
- Uncontrollable hypertension
- Serious cardiac or pulmonary dysfunction
- Renal failure
- Portal vein thrombosis
- History of organ transplantation
- History of HIV (human immunodeficiency viruses) infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of shunt dysfunction. 2 years
- Secondary Outcome Measures
Name Time Method Incidence of variceal rebleeding 2 years Incidence of hepatic encephalopathy 2 years Incidence of hepatic myelopathy 2 years Survival 2 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie shunt dysfunction in TIPS with 8- or 10-mm covered stents for cirrhosis?
How does TIPS with 10-mm covered stents compare to standard-of-care endoscopic therapy in preventing variceal rebleeding?
Are there specific biomarkers that predict response to TIPS using 10-mm versus 8-mm covered stents in decompensated cirrhosis patients?
What are the potential adverse events associated with 8- and 10-mm covered stents in TIPS procedures for portal hypertension?
How do combination therapies with beta-blockers and TIPS using 10-mm covered stents impact variceal rebleeding rates in cirrhotic patients?
Trial Locations
- Locations (1)
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases, Fourth Military Medical University🇨🇳Xi'an, Shaanxi, China