search
Back to results

Comparison of Covered and Bare Stent in TIPS

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
covered stent
bare stent
Sponsored by
Beijing Shijitan Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring TIPS, Hepatocellular Carcinoma, Portasystemic Shunt

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Shijitan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

covered stent

bare stent

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

restenosis/occlusion rate
The cumulative restenosis rate in 1, 2, 3, 4, or 5-year

Secondary Outcome Measures

recurrence rate of gastrointestinal bleeding
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
survival rate
The 1, 2, 3, 4 and 5-year survival rate
rate of secondary interventional therapy
rate of secondary interventional therapy
incidence rate of hepatic encephalopathy
The incidence rate of hepatic encephalopathy

Full Information

First Posted
August 27, 2015
Last Updated
September 1, 2015
Sponsor
Beijing Shijitan Hospital, Capital Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02540382
Brief Title
Comparison of Covered and Bare Stent in TIPS
Official Title
Comparison of Covered and Bare Stent in TIPS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Shijitan Hospital, Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
TIPS, Hepatocellular Carcinoma, Portasystemic Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
covered stent
Arm Type
Experimental
Arm Description
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.
Arm Title
bare stent
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
covered stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
bare stent
Intervention Description
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 Measure Information:
Title
restenosis/occlusion rate
Description
The cumulative restenosis rate in 1, 2, 3, 4, or 5-year
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
recurrence rate of gastrointestinal bleeding
Time Frame
up to 5 years
Title
recurrence rate of refractory hydrothorax/ascites
Description
the recurrence rate of refractory hydrothorax/ascites (including non-responders, recurrent, and newly developed cases) during the follow up
Time Frame
up to 5 years
Title
survival rate
Description
The 1, 2, 3, 4 and 5-year survival rate
Time Frame
up to 5 years
Title
rate of secondary interventional therapy
Description
rate of secondary interventional therapy
Time Frame
up to 5 years
Title
incidence rate of hepatic encephalopathy
Description
The incidence rate of hepatic encephalopathy
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianli Xu, MD, PhD
Organizational Affiliation
Beijing Shijitan Hospital of Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30079331
Citation
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.
Results Reference
derived

Learn more about this trial

Comparison of Covered and Bare Stent in TIPS

We'll reach out to this number within 24 hrs