NCT02540382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

8.9 years

First QC Date

August 27, 2015

Last Update Submit

September 1, 2015

Conditions

Cirrhosis

Keywords

TIPSHepatocellular CarcinomaPortasystemic Shunt

Outcome Measures

Primary Outcomes (1)

  • restenosis/occlusion rate

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

    up to 5 years

Secondary Outcomes (5)

  • recurrence rate of gastrointestinal bleeding

    up to 5 years

  • recurrence rate of refractory hydrothorax/ascites

    up to 5 years

  • survival rate

    up to 5 years

  • rate of secondary interventional therapy

    up to 5 years

  • incidence rate of hepatic encephalopathy

    up to 5 years

Study Arms (2)

covered stent

EXPERIMENTAL

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

bare stent

OTHER

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

Interventions

covered stentDEVICE

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

covered stent
bare stentDEVICE

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.

bare stent

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • portal hypertension patients with defined indications for TIPS treatment;
  • scheduled for elective TIPS; and
  • aged between 18-70 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

Related Publications (1)

  • 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.

    PMID: 30079331DERIVED

MeSH Terms

Conditions

FibrosisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jianli Xu, MD, PhD

    Beijing Shijitan Hospital, Capital Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Interventional Therapy

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 3, 2015

Study Start

January 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

CN(1)