Cirrhosis
Conditions
Keywords
TIPS, Hepatocellular Carcinoma, Portasystemic Shunt
Brief summary
Investigators aim to compare the efficacy of 8 mm Fluency covered stent and bare stent in transjugular intrahepatic portosystemic shunt (TIPS) for the treatment of cirrhotic portal hypertension.
Detailed description
From January 2006 to December 2010, the covered (experimental group) or bare stent (control group) was used in 131 and 127 patients, respectively. The recurrence rates of gastrointestinal bleeding and refractory hydrothorax/ascites, the cumulative restenosis rates in 1, 2, 3, 4, and 5-years, the incidence rate of hepatic encephalopathy, the rate of secondary interventional therapy, the 1, 2, 3, 4 and 5-year survival rates were compared between the experimental group and the control group.
Interventions
DEVICEcovered stent
A broad range of implant diameters and lengths for the treatment of in-stent restenotic peripheral and central lesions\* in patients with AV grafts and AV fistulae Small incremental stent graft lengths to help maintain venous real estate and cannulation area Minimal shortening and radiopaque markers aid in excellent placement accuracy
DEVICEbare stent
A one piece laser cut, self-expanding nitinol stent combining a micromesh design with a multi segmental construction. The 36 strut, 6 bridge construction of the Stent provides an unmatched balance of radial force, scaffolding, and longitudinal stability. The design offers crush recoverable flexibility in the most challenging vasculature, with optimal wall apposition, conformability and minimal foreshortening. It offers a broad portfolio of sizes for the treatment of routine and challenging Iliofemoral lesions.
Sponsors
Beijing Shijitan Hospital, Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. portal hypertension patients with defined indications for TIPS treatment; 2. scheduled for elective TIPS; and 3. aged between 18-70 years.
Exclusion criteria
1. combined with hepatic encephalopathy before the treatment; 2. combined with portal vein thrombosis; 3. combined with malignant liver tumor or malignancies at the other sites; or 4. combined with hemorrhage of gastrointestinal ulcer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| restenosis/occlusion rate | up to 5 years | The cumulative restenosis rate in 1, 2, 3, 4, or 5-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate of gastrointestinal bleeding | up to 5 years | — |
| recurrence rate of refractory hydrothorax/ascites | up to 5 years | the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up |
| survival rate | up to 5 years | The 1, 2, 3, 4 and 5-year survival rate |
| rate of secondary interventional therapy | up to 5 years | rate of secondary interventional therapy |
| incidence rate of hepatic encephalopathy | up to 5 years | The incidence rate of hepatic encephalopathy |
Countries
China
Outcome results
None listed