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Comparison of Covered and Bare Stent in TIPS

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ClinicalTrials.gov Identifier: NCT02540382
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Liu Fuquan, Beijing Shijitan Hospital

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Device: covered stent Device: bare stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Covered and Bare Stent in TIPS
Study Start Date : January 2006
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: covered stent

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
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

bare stent

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

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.





Primary Outcome Measures :
  1. restenosis/occlusion rate [ Time Frame: up to 5 years ]
    The cumulative restenosis rate in 1, 2, 3, 4, or 5-year


Secondary Outcome Measures :
  1. recurrence rate of gastrointestinal bleeding [ Time Frame: up to 5 years ]
  2. recurrence rate of refractory hydrothorax/ascites [ Time Frame: up to 5 years ]
    the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up

  3. survival rate [ Time Frame: up to 5 years ]
    The 1, 2, 3, 4 and 5-year survival rate

  4. rate of secondary interventional therapy [ Time Frame: up to 5 years ]
    rate of secondary interventional therapy

  5. incidence rate of hepatic encephalopathy [ Time Frame: up to 5 years ]
    The incidence rate of hepatic encephalopathy



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540382


Locations
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China, Beijing
Beijing Shijitan Hospital
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Beijing Shijitan Hospital
Investigators
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Study Chair: Jianli Xu, MD, PhD Beijing Shijitan Hospital of Capital Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu Fuquan, Department of Interventional Therapy, Beijing Shijitan Hospital
ClinicalTrials.gov Identifier: NCT02540382     History of Changes
Other Study ID Numbers: liufq_sjt
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Liu Fuquan, Beijing Shijitan Hospital:
TIPS
Hepatocellular Carcinoma
Portasystemic Shunt