Comparison of Covered and Bare Stent in TIPS

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Device: covered stent; Device: bare stent

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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Shijitan Hospital, Capital Medical University
• Investigators: Study Chair: Jianli Xu, MD, PhD, Beijing Shijitan Hospital of Capital Medical University

Publications and helpful links

General Publications

• Li HB, Yue ZD, Zhao HW, Wang L, Fan ZH, He FL, Dong XQ, Liu FQ. Pathological Features of Mitochondrial Ultrastructure Predict Susceptibility to Post-TIPS Hepatic Encephalopathy. Can J Gastroenterol Hepatol. 2018 Jul 16;2018:4671590. doi: 10.1155/2018/4671590. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; TIPS; Portasystemic Shunt
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: liufq_sjt