Comparison of Covered and Bare Stent in TIPS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Covered and Bare Stent in TIPS

Conditions
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Cirrhosis

Intervention / Treatment
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* Device: covered stent
* Device: bare stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: portal hypertension patients with defined indications for TIPS treatment; scheduled for elective TIPS; and aged between 18-70 years. Exclusion Criteria: combined with hepatic encephalopathy before the treatment; combined with portal vein thrombosis; combined with malignant liver tumor or malignancies at the other sites; or combined with hemorrhage of gastrointestinal ulcer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: covered stent<br>Procedure/Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm covered stents (Bard, Fluency). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No. | Device: covered stent<br>* 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<br>|
| Other: bare stent<br>Surgery: Jugular vein puncture and catheterization. Device: RUPS-100 (COOK Company) sheath, 8 mm balloon, Pigtail catheter, 8 mm bare stents (EV3, protégé; Cordis, Smart). Drug (including placebo): No Biological/Vaccine: No Radiation: No Behavioral (e.g., Psychotherapy, Lifestyle Counseling): No Genetic (including gene transfer, stem cell and recombinant DNA): No Dietary Supplement (e.g., vitamins, minerals): No. | Device: bare stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| restenosis/occlusion rate | The cumulative restenosis rate in 1, 2, 3, 4, or 5-year | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate of gastrointestinal bleeding |  | up to 5 years | 
| recurrence rate of refractory hydrothorax/ascites | the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up | up to 5 years | 
| survival rate | The 1, 2, 3, 4 and 5-year survival rate | up to 5 years | 
| rate of secondary interventional therapy | rate of secondary interventional therapy | up to 5 years | 
| incidence rate of hepatic encephalopathy | The incidence rate of hepatic encephalopathy | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIPS, Hepatocellular Carcinoma, Portasystemic Shunt